GEM Premier 4000 00025000000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08426950452591), received between Feb 21, 2017 and Oct 20, 2022 — classified as 1 death, 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Issue” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K093623, K112995, K133407); 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. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionOct 20, 2022No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER SUBMITTED A MEDWATCH USER FACILITY REPORT (B)(4) THAT INDICATED THAT A GEM PREMIER 4000 EXPERIENCED FOUR CONSECUTIVE CARTRIDGE FAILURES. AFTER THE REPORTED CARTRIDGE FAILURES, WERFEN SERVICE REPLACED THE HEATER ASSEMBLY WHICH RETURNED THE INSTRUMENT TO OPERATIONAL CONDITION. DATE OF EVENT INDICATED (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15642141 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A COMPLAINT INDICATING QUESTIONABLE FETAL SCALP PH RESULTS AFTER A PH RESULT OF 7.11 WAS DISPLAYED ON A GEM PREMIER 4000 SYSTEM. HOWEVER, THE RESULT COULD NOT BE RETRIEVED IN THE INSTRUMENT AFTER AN ERROR MESSAGE WAS DISPLAYED ("AIR DETECTED WITHIN SAMPLE. DISPLAYED RESULTS QUESTIONABLE"). BASED UPON THE DISPLAYED RESULT, THE PHYSICIAN WAS NOTIFIED, AND THE DECISION WAS MADE TO PROCEED WITH AN URGENT CAESARIAN SECTION.

  Patient problems: Pregnancy

  MAUDE report 9935381 ↗
• InjuryJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT STATED THAT THERE WERE TWO SETS OF BLOOD GAS SAMPLES ANALYZED ON GEM PREMIER 4000 SN (B)(4). THE OPERATOR ENTERED THE PATIENTS' FIRST AND LAST NAMES CORRECTLY INTO THE GEM BUT INCORRECTLY ENTERED THE MRNS (MEDICAL RECORD NUMBERS) . THE PRINTOUTS SHOW THE CORRECT PATIENT NAMES AND RESULTS AND THE INCORRECT MRNS. THE RESULTS WENT TO THE INCORRECT PATIENT EMR (ELECTRONIC MEDICAL RECORD). THERE WAS NO PATIENT IMPACT. THE RESULTS WERE CORRECTLY APPLIED TO THE CORRECT EMR AND REMOVED FROM THE INCORRECT EMR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7650838 ↗
• InjuryMar 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT DUE TO A SODIUM VALUE OF 128 MMOL/L ON GEM PREMIER 4000 LOCATED IN THE NICU, THE PATIENT'S SODIUM INTAKE WAS INCREASED. HOWEVER, WHEN THE LAB ANALYZER REPORTED A SODIUM VALUE OF 150 TEN HOURS LATER, THE GEM PREMIER 4000 SODIUM RESULT WAS QUESTIONED. THERE WAS NO PERCEIVED IMPACT TO THE PATIENT DUE TO THE INCREASED SODIUM INTAKE.

  Patient problems: Therapeutic Response, Increased

  MAUDE report 7361605 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT METHB AND COHB WERE ANALYZED ON THEIR GEM PREMIER 4000. PER LOCAL PRACTICE, THEIR RESULTS WERE MANUALLY TRANSCRIBED FROM TICKER TAPE TO THEIR LABORATORY INFORMATION SYSTEM TO CONVERT TO SI UNITS. THE MANUAL TRANSCRIPTION REQUIRES THAT STAFF MULTIPLY THE TICKER TAPE RESULTS BY 0.01 TO OBTAIN THE FRACTION VALUE FOR COHB AND METHB. HOWEVER, THE OPERATOR FAILED TO DO THIS AND THE PATIENT WAS BELIEVED TO HAVE A METHB OF 80%. BASED ON THEIR CALCULATION ERROR, THE PHYSICIAN INAPPROPRIATELY ADMINISTERED METHYLENE BLUE TO THE PATIENT. PER THE CUSTOMER, THE PATIENT REQUIRED "SERIOUS INTERVENTION" AND HAD AN EXTENDED HOSPITAL LENGTH OF STAY. PER THE CUSTOMER, THE GEM PREMIER 4000 SYSTEM OPERATED TO SPECIFICATION. THE ERROR WAS DUE TO MANUAL CALCULATION ERRORS WHEN CONVERTING FROM % TO SI UNITS.

  Patient problems: Therapeutic Response, Increased

  MAUDE report 7328352 ↗
• MalfunctionApr 7, 2017Device Issue; Adverse Event Without Identified Device or Use Problem; Device Issue; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PH RESULTS BETWEEN TWO DIFFERENT GEM 4000 ANALYZERS (SOFTWARE VERSION 2.3.0) WERE INCONSISTENT. THE CUSTOMER RECEIVED A PH VALUE OF 7.32 (ARTERIAL SAMPLE) FROM THE DELIVERY ROOM INSTRUMENT AT 17:47 AND A PH OF 7.40 (VENOUS SAMPLE) JUST OVER A MINUTE LATER ON THE INSTRUMENT IN THE NEONATAL INTENSIVE CARE UNIT. AS A RESULT OF THE FIRST PH MEASUREMENT, THE MEDICAL TEAM DECIDED TO PERFORM A CAESARIAN SECTION; HOWEVER, BASED UPON THE SECOND, HIGHER RESULTS THE MEDICAL TEAM CONCLUDED THAT THE CAESARIAN SECTION PERFORMED WAS UNNECESSARY, NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6471281 ↗
• DeathFeb 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REQUESTED INSTRUMENTATION LABORATORY (IL) TO REVIEW TWO GLUCOSE RECOVERIES FROM A GEM PREMIER 4000 INSTRUMENT. BOTH SAMPLES WERE FROM THE SAME PATIENT. THE SAMPLES WERE ANALYZED ON (B)(6) 2016. THE FIRST SAMPLE ANALYZED AT 12:56 PRODUCED AN INCALCULABLE GLUCOSE RESULT. THE SECOND SAMPLE ANALYZED AT 13:37 PRODUCED A GLUCOSE RESULT OF >41.6 MMOL/L. IL WAS INFORMED THAT THE PATIENT DIED LATER.

  Patient problems: Death

  MAUDE report 6347313 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093623, K112995, K133407. One submission often covers many models, so check the product and lot details in each record.

• Z-2804-2011 · May 31, 2011 · Terminated
  GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox 75 test iQM Part Number : 00027407510 150 test iQM Part Number:00027415010 300 test iQM Part Number: 0
• Z-2803-2011 · May 31, 2011 · Terminated
  GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/CO-Ox 75 test iQM Part Number: 00027407508 150 test iQM Part Number: 00027415008 300 test iQM Part Number :
• Z-2805-2011 · May 31, 2011 · Terminated
  GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/CO-Ox/tBili 75 test iQM Part Number: 00027407509 150 test iQM Part Number: 00027415009 300 test iQM Part Numbe
• Z-2806-2011 · May 31, 2011 · Terminated
  GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox/tBili : 75 test iQM Part Number:00027407511 150 test iQM Part Number: 00027415011 300 test iQM Part N
• Z-2165-2011 · Feb 14, 2011 · Terminated
  Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole bl