MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER

Model Number 393-090

Device Problems Incorrect Measurement (1383); High Readings (2459); Low Readings (2460)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2020

Event Type  malfunction  

Event Description

According to the complaint, a customer reports that an abl90 flex analyzer gave discrepant results for patient measurements for the hemoglobin parameter at (b)(6) 2020: for all patients the sample was drawn and tested at the same time patient 1, no.483937.6:00h hemoglobin value: abl90 flex: 38g/l; cbc: 104g/l at 8:00 a.M.Patient 4, no.485013.6:00h hemoglobin value: abl90 flex:166g/l; cbc: 94g/l at 8:00 a.M.Patient 6, no.485586.6:00h hemoglobin value: abl90 flex:190g/l; cbc: 112g/l at 8:00 a.M.Patient 7, no.132237.6:00h hemoglobin value: abl90 flex:186g/l; cbc: 66g/l at 8:00 a.M.On (b)(6) 2020 patient 7 was tested again.The sample was drawn and tested at the same time: patient 7, no.132237.6:00h hemoglobin value: abl90 flex:1.3g/l; cbc result was 69g/l at 8:00 a.M.Based on the measurements above, the discrepancies have been calculated to: (b)(6).The customer reports that, several patient results were seriously different from patients' condition, which effected the doctor's judgement, and played a misleading role.The customer has stopped using the analyzer.

Manufacturer Narrative

From the radiometer investigation performed it was found that quality controls and calibrations were ok, and that the thb deviations are most likely caused by either: bad mixing of the sample or clots in the sample.In component codes, code 4756 has been chosen as there are no code that fits the description for this event.The radiometer investigation does not point to that a component in the analyzer was the cause for this event.

• 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: 10223076
• MDR Text Key: 212561093
• Report Number: 3002807968-2020-00026
• 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
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• 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?: Yes
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1