MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX PLUS ANALYZER

Model Number 393-092

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

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

Event Date 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

Health professional should be "no information".

Event Description

According to the complaint, a customer states that they experienced deviating results for the na, and ca parameter when measuring blood samples with an abl90 flex plus analyzer ((b)(4)).The customer performed comparison measurement with another abl90 flex analyzer and the biggest discrepancy has been calculated below: na (mmol/l) ca (mmol/l) abl90 flex plus 134 1,05, comparison 144 1, 23, discrepancy -10 -0,18.

Manufacturer Narrative

From the radiometer investigation it was found that the incident was due to the use of disinfection wipes to clean the inlet probe.The customer does not use disinfection wipes anymore.Health effects - health impact code: 2199.

• Brand Name: ABL90 FLEX PLUS ANALYZER
• Type of Device: ABL90 FLEX PLUS
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 9909496
• MDR Text Key: 203481890
• Report Number: 3002807968-2020-00013
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693930923
• UDI-Public: (01)05700693930923
• Combination Product (y/n): N
• PMA/PMN Number: K160153
• 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: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 393-092
• Device Catalogue Number: 393-092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1