MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER

Model Number 393-090

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2019

Event Type  malfunction  

Event Description

According to the complaint, customer sample from a baby was measured on an abl90 flex analyzer (serial number (b)(4) with a result for bilirubin of 0 mol/l despite no error message.The bilirubin was measured in the same patient with other analyzers with a value of approximately 100 mol/l.Based on the series of measurements, the customer reports the result of 0 umol/l as impossible as a newborn child may not have a concentration of bilirubin of 0.

Manufacturer Narrative

On 2019-12-27 radiometer received the hemolyzer unit and the spectrometer unit from the affected abl90 analyzer for further investigation.The method code in field h6 has been updated to include investigation of actual device.

Manufacturer Narrative

By investigation of the log it has been observed that measurements before the reported sample (sample #22517) and after have no tbil deviation.Radiometer have not been able to reproduce the error.However, it has been evaluated that the cuvette part of the hemolyzer unit is worn.Radiometer has not able to determine root cause for the discrepant tbil measurement reported by the customer.It could be related to the worn cuvette in the hemolyzer or to the specific sample itself.

• Brand Name: ABL90 FLEX ANALYZER
• Type of Device: ABL90 FLEX ANALYZER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 9283639
• MDR Text Key: 199095598
• Report Number: 3002807968-2019-00053
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909
• 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,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 393-090
• Device Catalogue Number: 393-090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Date Manufacturer Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1