MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER

Model Number 393-090

Device Problem Low Readings (2460)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/18/2022

Event Type  malfunction  

Event Description

According to the complaint, on (b)(6) 2022 a sample was measured on the abl90 flex analyzer (serial number: (b)(4)) and the following measurements were obtained on the sodium (na) parameter: 21:38 138 mmol/l, 21:39 121 mmol/l, 22:22 107 mmol/l, 22:24 107 mmol/l.A control ionogram was conducted with the sample and the following measurement was obtained on the sodium (na) parameter: 137 mmol/l (comparison measurement).Based on these measurements, the customer reported the last 3 results from the abl90 flex analyzer as false low.

Manufacturer Narrative

The radiometer investigation has found that the root cause was due to pre-analytical sample preparation, where the sample was not homogeneous.This led to the reported discrepant results.Hence the abl90 flex analyzer was found to have not failed.

• Brand Name: ABL90 FLEX ANALYZER
• Type of Device: ABL90 FLEX ANALYZER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer Contact: pearlyn pah ; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 14914197
• MDR Text Key: 303922986
• Report Number: 3002807968-2022-00024
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R0230N010
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K092686
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/05/2022
• Supplement Dates Manufacturer Received: 07/07/2022
• Supplement Dates FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female
• Patient Weight: 6 KG