MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX; ABL800 FLEX WITH CREA

Model Number	393-801
Medical Device Problem Codes	Use of Device Problem (1670); Low Readings (2460)
Health Effect - Clinical Code	Renal Impairment (4499)
Date of Event	10/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the complaint, a false low creatinine result of 0.35 mg/dl was measured on the radiometer abl800 analyzer for a (b)(6) female patient.A comparison measurement of 9.54mg/dl was obtained from the central laboratory.Based on the abl800 result, the hospital initiated unnecessary treatment with contrast agent.It was reported that due to the treatment the patient experienced kidney insufficiency.
Additional Manufacturer Narrative
The investigation concluded that the analyzer worked as intended by marking the patient result with "?" meaning that the result was unreliable.It was thus a use error to use the result clinically.

• Brand Name: ABL800 FLEX
• Common Device Name: ABL800 FLEX WITH CREA
• 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: kristina friis olsson ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 12819493
• Report Number: 3002807968-2021-00060
• Device Sequence Number: 12131423
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R1271N007
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041874
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 393-801
• Device Catalogue Number: 393-801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2012
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female