MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number 393-800

Device Problem Low Test Results (2458)

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

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

The event date is estimated.

Event Description

The customer reported that in the last weeks, too low ica values were measured on the abl800 flex analyzer.The described error resulted in several patients in the operating room being treated with intravenous calcium, but no permanent damage was reported.Measurements on the affected device (serial no.(b)(4)) compared with two other devices are shown in the table below.Abl800 sn: (b)(4).Abl800 sn: (b)(4).Abl800 sn: (b)(4).(b)(6).

Manufacturer Narrative

The following additional information has been received from the customer: " since (b)(6), 153 measurements have been performed with the device, where ca++ has been measured in 40 analyses in the reference range, 5 analyses above the reference range and 108 analyses below the reference range.Compared to the previous months, these are a striking number of measurements where the ca++ is below the reference range.Only in one patient did we have a measurement on another device in the same period, which showed a ca++ in the reference range at initial ca++ below the reference range during the control measurement.Both measuring chambers were inspected by the field service engineer and damages was observed.The cylinders were not fixed well anymore.The ca++ and reference electrodes including used membranes will be returned to radiometer for investigation.

Manufacturer Narrative

The failing calcium membrane unit has been investigated in light microscope.Appearance of mempack and sensor front were as expected for a used calcium membrane unit.Therefore, it was not possible to determine closer the root cause to the failure of this membrane unit.

• Brand Name: ABL800 FLEX
• Type of Device: ABL800 FLEX
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 9127582
• MDR Text Key: 204370402
• Report Number: 3002807968-2019-00043
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K041874
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 393-800
• Device Catalogue Number: 393-800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 09/30/2019; 01/13/2020
• Supplement Dates FDA Received: 10/28/2019; 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1