MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER

Model Number	393-090
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer reference number: (b)(4) according to the complaint the customer experienced false high glucose (glu) results on their abl90 flex analyzer (serial no; (b)(6).The hospital reported, on the morning of (b)(6) 2025, the doctor ordered an arterial blood draw to test blood gases, lactate, glucose, and electrolytes.After drawing the blood, the nurse performed the test on the abl90 flex analyzer.The result showed a glucose level of 18.8 mmol/l, which was reported to the doctor.The doctor instructed a repeat test using a rapid glucose meter, which yielded a value of 7.7 mmol/l.Suspecting a malfunction of the sensor cassette (lot; r0321) in the analyzer, the medical staff immediately contacted the engineer.The engineer instructed to recalibrate twice.After completing the recalibration, a follow-up test was performed, and the glucose result was 4.2 mmol/l, which is within the normal range.No adverse effects were observed in the patient.
Additional Manufacturer Narrative
The radiometer investigation has not been able to identify the specific root cause in this complaint due to lack of data, parts and details.Hence, the root cause is unknown.
Event or Problem Description
Radiometer reference number: (b)(4).According to the complaint the customer experienced false high glucose (glu) results on their abl90 flex analyzer (serial no; (b)(6).The hospital reported, on the morning of (b)(6) 2025, the doctor ordered an arterial blood draw to test blood gases, lactate, glucose, and electrolytes.After drawing the blood, the nurse performed the test on the abl90 flex analyzer.The result showed a glucose level of 18.8 mmol/l, which was reported to the doctor.The doctor instructed a repeat test using a rapid glucose meter, which yielded a value of 7.7 mmol/l.Suspecting a malfunction of the sensor cassette (lot; r0321) in the analyzer, the medical staff immediately contacted the engineer.The engineer instructed to recalibrate twice.After completing the recalibration, a follow-up test was performed, and the glucose result was 4.2 mmol/l, which is within the normal range.No adverse effects were observed in the patient.Information received from the customer (b)(6) 2025: after the analyzer detected a result of 18.8 mmol/l, the engineer inspected the analyzer and confirmed that both calibration and qc were normal, with no alarms triggered by the analyzer.The customer then performed two calibrations and repeated the sampling process, after which the test result returned 4.2.No repairs were carried out, and subsequent test results for other patients were all normal.

• Brand Name: ABL90 FLEX ANALYZER
• Common Device Name: ABL90 FLEX ANALYZER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer Contact: ditte krøyer ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 23050539
• Report Number: 3002807968-2025-00115
• Device Sequence Number: 9769171
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R1075N093
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 393-090
• Device Catalogue Number: 393-090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 3 DA
• Patient Sex: Male