GEM PREMIER 5000
Received May 6, 2026 · Event occurred Apr 25, 2026
Report 1217183-2026-00006 · MDR key 25101120
Device
Generic name
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Manufacturer
Instrumentation Laboratory Co.Catalog number
00024019255
Product problems
- Patient Data Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
WE HAVE CONFIRMED CUSTOMER REPORTS OF BAR CODE READER (BCR) WANDS ON THE GEM PREMIER 5000 AND GEM PREMIER 7000 ASSIGNING PATIENT RESULTS TO THE INCORRECT PATIENT ID. THIS ISSUE IS DUE TO A MALFUNCTION INTRODUCED DURING A RECENTLY RELEASED CONFIGURATION UPDATE TO THE BCR WANDS ON OR AFTER (B)(6) 2026. A CLASS II RECALL WILL BE INITIATED TO ADVISE CUSTOMERS OF THIS POTENTIAL PERFORMANCE ISSUE, INSTRUCTING THEM TO IMMEDIATELY DISCONTINUE USE OF THE AFFECTED WANDS AND TO MANUALLY ENTER PATIENT ID UNTIL THE WANDS ARE REPLACED. A 21 CFR 806 REPORT WILL BE FILED WITH THE APPROPRIATE FDA OII RECALL COORDINATOR.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE BAR CODE READER (BCR) WAND USED ON THEIR GEM PREMIER 5000 INSTRUMENT ASSIGNED PATIENT RESULTS TO THE INCORRECT PATIENT ID. THERE IS NO KNOWN PATIENT IMPACT.
Remedial action
- Recall