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

Model Number 393-092

Device Problem Low Test Results (2458)

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

Event Date 01/04/2019

Event Type  malfunction  

Manufacturer Narrative

Please note that no udi number is available for this affected device.The udi number is blank, as this product was manufactures before udi numbers was implemented at radiometer.

Event Description

According to the complaint received, a deviation for more than 50% was observed for the bilirubin parameter on abl90 flex plus analyzer placed in the delivery room.Two samples were measured at clinic, where the problem was reported ((b)(6)) and compared to measurements performed in the laboratory and measurements performed at another clinic ((b)(6)).The following bilirubin results were measured: sample 1 -(b)(6): 67 umol/l, abl90 flex analyzer.Sample 1 -(b)(6) (laboratory): 71 umol/l, abl90 flex analyzer.Sample 1 -(b)(6) (delivery room): 24 umol/l, abl90 flex plus analyzer.Sample 2 -(b)(6): 74 umol/l, abl90 flex analyzer.Sample 2 -(b)(6) (lab): 68 umol/l, abl90 flex analyzer.Sample 2 -(b)(6) (delivery): 17 umol/l, abl90 flex plus analyzer.Based on the above measurement it was reported that the abl90 flex plus analyzer in the delivery room demonstrated a low bias for more than <50% compared to the measurements performed on abl90 flex analyzers.There was no reports of serious injury or maltreatment in relation to this case.

Manufacturer Narrative

The investigation performed by radiometer medical aps concluded that the measurements would have been correct if the instrument setting had been correct having the hbf correction setting 'enabled for levels > 20%' activated, which is the default setting.

• Brand Name: ABL90 FLEX PLUS ANALYZER
• Type of Device: ABL90 FLEX PLUS ANALYZER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 8284492
• MDR Text Key: 136614244
• Report Number: 3002807968-2019-00003
• Device Sequence Number: 1
• Product Code: MQM
• 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: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 393-092
• Device Catalogue Number: 393-092
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1