Model note · Blood Gas Analyser
Werfen GEM Premier 5000
The GEM Premier 5000 is a cartridge based whole blood analyser for blood gases, electrolytes, metabolites, CO-oximetry and total bilirubin, used at the point of care and in central labs. Almost every wetted part, including sensors, calibration solutions, pump tubing, valve and waste bag, lives in a disposable GEM PAK that is swapped about once a month. Quality control is handled by iQM2, which runs continuous automated checks before, during and after each sample instead of relying only on scheduled liquid QC.
The model
Maker, model and type.
- Maker
- Instrumentation Laboratory Co. (Werfen)
- Model
- GEM Premier 5000
- Device type
- Blood Gas Analyser
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Measured analytes | pH, pCO2, pO2, Na, K, iCa, Cl, glucose, lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, tBili, sO2 | Source |
| Measurement ranges (blood gas) | pH 7.00 to 7.92; pCO2 6 to 125 mmHg; pO2 6 to 690 mmHg | Source |
| Sample volumes | 150 uL syringe or capillary (normal mode); 100 uL capillary with tBili/CO-Ox; 65 uL capillary micro mode | Source |
| Sample handling | Lithium heparin whole blood, analysed within 15 minutes of draw; 2 point calibration | Source |
| GEM PAK sizes and use life | 75 to 600 tests; 31 days on board (21 days for the 600 test PAK); no refrigeration needed | Source |
| Measurement principles | Potentiometry for pH and pCO2; amperometric three electrode cell with platinum working electrode for pO2 | Source |
| Hct and tHb method | Hct by conductivity (Maxwell-Fricke relation); tHb and CO-Ox by absorbance of lysed sample in a flow through optical cell | Source |
| Altitude | No significant effect on pH, pCO2 or pO2 from sea level to 10,000 ft (3,050 m) | Source |
| Operating system change | Instrument OS moved from Fedora 17 Linux to WindRiver LTS 18 Linux (K203790) | Source |
| FDA basis | K160412 for pH, pCO2, pO2 (predicate GEM Premier 4000, K133407), 21 CFR 862.1120, product code CHL, Class II | Source |
Recalls
Known FDA recalls.
- Z-2900-20262026-05-21
Lysing bag solution in specific GEM Premier 5000 PAK lots out of specification, risking delayed recognition of CO-Ox and bilirubin abnormalities.
FDA record - Z-2821-20262026-05-08
Bar code reader wands used with GEM Premier 5000 and 7000 could assign results to the wrong patient ID (several record numbers, Z-2821 to Z-2826).
FDA record - Z-1524-20262026-01-20
Higher rate of PCSND errors during PAK warm up causing ejection; correction covered many PAK part numbers (Z-1524 to Z-1543-2026).
FDA record
Safety
Safety warnings from the record.
- Wrong patient ID assignment from a faulty bar code wand can attach results to the wrong patient; confirm identity before acting on results. Source
- Repeated PAK ejections during warm up can delay results, so plan backup testing for critical areas. Source
- Capillary claims for pCO2, potassium, chloride, Hct and tHb were only added later (K173403), so check which labelling version applies before reporting capillary results for these. Source
- The analyser aids diagnosis and treatment of life threatening acid base disturbances, so analytical errors carry real clinical risk; prescription use only. Source
Sources
Where this note comes from.
- Werfen GEM Premier 5000 product page (North America)
- FDA decision summary K160412, GEM Premier 5000 pH, pCO2, pO2
- FDA decision summary K173403, GEM Premier 5000 capillary claims
- FDA decision summary K203790, GEM Premier 5000 OS change
- openFDA recall search, GEM Premier 5000
- openFDA MAUDE problem counts, GEM Premier 5000
Not covered: The operator and service manuals sit behind Werfen's login, so the analyser's error message list, iQM2 failure pattern codes, dimensions, weight and power data are not included; the only error named is PCSND from a recall record. Electrolyte, metabolite and CO-Ox ranges from K160225, K160402 and K160415 were not added. There are 26 recall records for this model, all in 2026, grouped here into three events. MAUDE has only about 20 reports, too few for a reliable trend.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Blood Gas Analyser
Other models of this device.
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