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

Model Number 393-801

Device Problems Use of Device Problem (1670); Low Readings (2460)

Patient Problem Renal Impairment (4499)

Event Date 10/16/2021

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 280812199
• Report Number: 3002807968-2021-00060
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R1271N007
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Female