GEM Premier 5000 00024019255Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08426950870227), received between Aug 15, 2018 and Sep 17, 2025 — classified as 5 deaths, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Date/Time-Related Software Problem” (1 report).

5 FDA recall records name this device's identifier, 5 still open.

21 other recalls cover devices cleared under the same FDA submission (K160412, K173403, K203790); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. May 8, 2026Open, Classified

   BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.

   Z-2825-2026 · Root cause: Software Design Change · Recall details · FDA record ↗

2. May 8, 2026Open, Classified

   BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.

   Z-2824-2026 · Root cause: Software Design Change · Recall details · FDA record ↗

3. May 8, 2026Open, Classified

   BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.

   Z-2823-2026 · Root cause: Software Design Change · Recall details · FDA record ↗

4. May 8, 2026Open, Classified

   BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.

   Z-2826-2026 · Root cause: Software Design Change · Recall details · FDA record ↗

5. May 8, 2026Open, Classified

   BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.

   Z-2821-2026 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• DeathSep 17, 2025Date/Time-Related Software Problem; Date/Time-Related Software Problem

  ON AUGUST 28, 2025, THE MANUFACTURER RECEIVED A CUSTOMER COMPLAINT REPORTING TIME DISCREPANCY IN BLOOD GAS ANALYSIS PERFORMED ON THE GEM PREMIER 5000. ON (B)(6) 2024, THERE WAS A DISCREPANCY OF APPROXIMATELY 20 MINUTES BETWEEN THE ACTUAL TIME AND THE TIME DISPLAYED ON THE GEM PREMIER 5000. THERE WAS NO REPORT OF ANY MALFUNCTION WITH THE BLOOD GAS ANALYZER AT THE TIME OF USE.

  Patient problems: Abnormal Blood Gases; Insufficient Information

  MAUDE report 23076973 ↗
• MalfunctionApr 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER REPORTED FLAMES COMING FROM THE TRIPPLITE UPS (PN 00025002112) USED WITH THEIR GEM PREMIER 5000. IT WAS REPORTED THAT THE GEM PREMIER 5000 ANALYZER WAS ON A MOBILE CART ABOVE THE UPS AND WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752272 ↗
• DeathJun 30, 2023Use of Incorrect Control/Treatment Settings; Insufficient Device Problem Information; Use of Incorrect Control/Treatment Settings; Insufficient Device Problem Information

  CUSTOMER REPORTED THAT CONNECTION WITH LIS WAS IN AN UNSTABLE STATE (CONNECTIONS/DISCONNECTIONS). THE GEM PREMIER 5000 CONNECTIONS AND TRANSFERS TO GWP WERE AFFECTED. DURING THE VARIOUS DISCONNECTIONS, A 10-YEAR-OLD PATIENT WAS IN ABSOLUTE EMERGENCY. THIS PATIENT NEEDED TO HAVE A GASOMETRY PERFORMED TO ADAPT HIS TREATMENT. ALL INSTRUMENTS IN THE EMERGENCY DEPARTMENT (OUTSOURCED BIOLOGY) DID NOT WORK AND WERE UNABLE TO CARRY OUT THE REQUESTED EXAMINATION, THE PATIENT WAS ADMITTED ON (B)(6) 2023 AT 3:19. CUSTOMER REPORTED THAT BLOOD GAS RESULTS WERE PROVIDED AT 5:02PM. THE MANUFACTURER WAS INFORMED ON JUNE 7TH 2023 THAT THE PATIENT DIED ON (B)(6) 2023, CAUSE OF DEATH WAS NOT SHARED.

  Patient problems: Fall

  MAUDE report 17239800 ↗
• InjuryAug 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT A SAMPLE WAS ANALYZED ON A PATIENT AND THE INCORRECT PATIENT IDENTIFIER WAS ENTERED. HOWEVER, ON NOTICING THIS INCIDENT, THE POCT LOOKED IN THE RESULTS ON THE LIS AND NOTICED THAT THE RESULTS HAD TRANSFERRED TO THE LIS (APEX) UNDER THE CORRECT PATIENT IDENTIFIER AND NOT TO THE INCORRECT PATIENT IDENTIFIER. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7799187 ↗
• DeathAug 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS RECEIVED INDICATING A DEATH IN A PATIENT WHO DEVELOPED HYPOGLYCEMIA FOLLOWING A MEDICATION ERROR WHERE INSULIN WAS ADMINISTERED INSTEAD OF HEPARIN BECAUSE OF AN INCORRECTLY LABELED SYRINGE PUMP. THE COMPLAINT STATES THAT ARTERIAL SAMPLES WERE TESTED ON MULTIPLE GEM PREMIER 5000 ANALYZERS ON (B)(6) 2018. THE ELECTROCHEMICAL RESULTS WERE NOT REPORTED AND THERE WERE NO ERROR MESSAGES. AS A RESULT, THE COMPLAINT ALLEGES A DELAY IN OBTAINING GLUCOSE RESULTS, WHICH IF AVAILABLE SOONER COULD HAVE ASSISTED THE CLINICAL TEAM WITH THE PATIENT MANAGEMENT.

  Patient problems: Death

  MAUDE report 7784100 ↗
• DeathAug 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS RECEIVED INDICATING A DEATH IN A PATIENT WHO DEVELOPED HYPOGLYCEMIA FOLLOWING A MEDICATION ERROR WHERE INSULIN WAS ADMINISTERED INSTEAD OF HEPARIN BECAUSE OF AN INCORRECTLY LABELED SYRINGE PUMP. THE COMPLAINT STATES THAT ARTERIAL SAMPLES WERE TESTED ON MULTIPLE GEM PREMIER 5000 ANALYZERS ON (B)(6) 2018. THE ELECTROCHEMICAL RESULTS WERE NOT REPORTED AND THERE WERE NO ERROR MESSAGES. AS A RESULT, THE COMPLAINT ALLEGES A DELAY IN OBTAINING GLUCOSE RESULTS, WHICH IF AVAILABLE SOONER COULD HAVE ASSISTED THE CLINICAL TEAM WITH THE PATIENT MANAGEMENT.

  Patient problems: Death

  MAUDE report 7784076 ↗
• DeathAug 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS RECEIVED INDICATING A DEATH IN A PATIENT WHO DEVELOPED HYPOGLYCEMIA FOLLOWING A MEDICATION ERROR WHERE INSULIN WAS ADMINISTERED INSTEAD OF HEPARIN BECAUSE OF AN INCORRECTLY LABELED SYRINGE PUMP. THE COMPLAINT STATES THAT ARTERIAL SAMPLES WERE TESTED ON MULTIPLE GEM PREMIER 5000 ANALYZERS ON (B)(6) 2018. THE ELECTROCHEMICAL RESULTS WERE NOT REPORTED AND THERE WERE NO ERROR MESSAGES. AS A RESULT, THE COMPLAINT ALLEGES A DELAY IN OBTAINING GLUCOSE RESULTS, WHICH IF AVAILABLE SOONER COULD HAVE ASSISTED THE CLINICAL TEAM WITH THE PATIENT MANAGEMENT.

  Patient problems: Death

  MAUDE report 7784056 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160412, K173403, K203790. One submission often covers many models, so check the product and lot details in each record.

• Z-2900-2026 · May 21, 2026 · Open, Classified
  GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
• Z-1530-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055407510.
• Z-1541-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Part No. 00055445004.
• Z-1525-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055360008.
• Z-1538-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Part No. 00055430008.
• Z-1535-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Part No. 00055415010.
• Z-1527-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055360011.
• Z-1524-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK, Part No. 00055360004.
• Z-1540-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Part No. 00055430011.
• Z-1536-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Part No: 00055415011.
• Z-1531-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055407511.
• Z-1528-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055407504.
• Z-1526-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055360010.
• Z-1534-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Part No. 00055415008.
• Z-1539-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Model No. 00055430010.

…and 6 more.