MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER

Model Number 393-090

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/24/2020

Event Type  malfunction  

Manufacturer Narrative

Health professional should be "no information".

Event Description

According to the complaint, a customer reports that an abl90 flex analyzer ((b)(4)) gave discrepant results for the thb parameter when measuring patient samples.Sample id (b)(6) ((b)(6) 2020, 12:23 p.M.): thb = 4,0 g/dl (measured too low).Sample id (b)(6) ((b)(6) 2020, 12:45 p.M.): thb = 5,3 g/dl (measured too low).Sample id (b)(6) ((b)(6) 2020, 12:52 p.M.): thb = 0,90 g/dl (measured too low).The customer reports that the patients were expected to be within the range of 11-17 g/dl.The largest discrepancy has been calculated to give the following values: sample id (b)(6): 13 g/dl, sample id (b)(6): 11,7 g/dl, sample id (b)(6): 16,1 g/dl.

Manufacturer Narrative

The returned hemolyzer has been investigated internally for thb deviations.Radiometer have seen no deviations in measurement performance when installing the returned hemolyzer in abl90 flex plus analyzers.The root cause for the thb deviation is not caused by the hemolyzer and it is most likely caused by pre-analytical handling.Further, the field service engineer has performed yearly maintenance, cleaned the analyzer, and installed a new hemolyzer.This case relates to another incident (3002807968-2020-00010) involving the same analyzer.

• Brand Name: ABL90 FLEX ANALYZER
• Type of Device: ABL90 FLEX ANALYZER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 9817125
• MDR Text Key: 202074304
• Report Number: 3002807968-2020-00006
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K092686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 393-090
• Device Catalogue Number: 393-090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1