MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER

Model Number	393-090
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth is estimated.
Event or Problem Description
Radiometer reference (b)(4).According to the complaint, on (b)(6) 2025, the medical staff conducted tests on a patient for blood gas, blood oxygen, and electrolytes.The abl90 flex analyzer (serial number (b)(6) measured a potassium level of 6.5 mmol/l, while the biochemical equipment measured a potassium level of 4.25 mmol/l, resulting in a difference of 2.25 mmol/l.The analyzer's potassium measurement was inaccurate, indicating a critical value.Due to the analyzer's high potassium reading, the child was monitored with an ecg, and the nutritional solution in use was replaced, seriously interfering with clinical work.
Additional Manufacturer Narrative
F code changed from f15 to f10.No system measage or error present in the calibration log or quality control log account for this higher result.Higher k readouts of this level in newborns are typically associated with hemolysis, as newborn blood samples are fragile and need to be sampled in a careful manner.When using a capillary tube with balanced heparin for newborns, the sample needs to be mixed right away after collection but in a gentle manner.Not mixing right away can result in clotting, giving a higher k readout.At the same time, mixing too vigorously can cause hemolysis in fragile samples like newborn blood samples.In conclusion, hemolysis is the most possible root cause.As the device didn't malfunction, this event no longer meet the criteria of an mdr reportable event.
Event or Problem Description
Radiometer complaint ref.(b)(4).

• 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: 22436153
• Report Number: 3002807968-2025-00091
• Device Sequence Number: 4592935
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R1118N001
• 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): 08/08/2025

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: 06/24/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• 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: 12 YR
• Patient Sex: Female