MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER

Model Number	393-090
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer reference (b)(4).According to the complaint, during a routine blood gas test for a patient, the nurse observed abnormal values from the abl90 flex (serial number (b)(6) for glucose of 1.2 mmol/l and lactate of 1.7 mmol/l.To ensure accuracy, the nurse replaced the abl90 flex solution pack (lot number dy26) and repeated the test, which then returned normal values of 6.8 mmol/l for glucose and 1 mmol/l for lactate.
Additional Manufacturer Narrative
The customer complained about glucose and lactate measurements results of the same patient deviating after inserting a new sensor cassette in abl90 flex.In this case, c(glu) = 1.2 mmol in the first and c(glu) = 6.8 mmol in the second measurement and c(lac)=1.7 mmol in the first and c(lac)=1.0 mmol in the second measurement.The investigation showed that one of the measurements was conducted while calibration errors (210) were present for both sensors during the first measurement.These errors were present since both sensors' calibrations were outside of range and drifting, which is normal during the startup period of the sensors.Therefore, the first measurement can not be considered precise and should not be used for diagnosis, as the instrument clearly signaled by sending an error code and marking the measurement with a question mark.Recommendation: please wait until the instrument is ready after startup of a new sensor cassette (parameter marked green) and monitor calibration error codes when measuring patient samples.Based on above conclusion, this event does not meet the definition of an mdr reportable event.

• 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: tom engdahl ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 22950542
• Report Number: 3002807968-2025-00112
• Device Sequence Number: 8530156
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R0852N030
• 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): 09/23/2025

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: 08/06/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2016
• 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: 61 YR
• Patient Sex: Male