MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX; ABL800 FLEX WITH CREA

Model Number 393-801

Device Problems High Test Results (2457); Calibration Problem (2890)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2017

Event Type  malfunction  

Event Description

According to the customer, on at least 2 occasions after re-membraning the reference electrode and passing qc, the results for sodium is higher than usual.This occurred with different lot numbers of reference membranes too and usually within the first few hours and within 24-36 hours.It has only occurred on one occasion since and since they've re-membraned it was ok.The customer compared results of sodium and potassium between their lab vitros analyzer and lab abl analyzer.The results were about 10 higher on the abl analyzer.The customer reports, that they've left a sign on the ed machine post reference re-membraning stating not to use the analyzer so that the customer could run qc etc.However, because all was green (and in fact the qc passed), ed decided to use the analyzer.The senior scientist has a gut feeling and thinks that they only were running one point calibration and that was not enough, so they run two 2 point calibrations now.Their process now is that they will not allow operators to use them until the appropriate double checks have been run after re-membraning.This is time consuming and difficult for the lab staff.

Manufacturer Narrative

Radiometer considers this case closed.

• Brand Name: ABL800 FLEX
• Type of Device: ABL800 FLEX WITH CREA
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej 21, DK-27 00; DA DK-2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, DK-27 00; DA DK-2700
• Manufacturer Contact: tom engdahl ; aakandevej 21; broenshoej, DK-27-00 ; DA DK-2700 ; 538273216
• MDR Report Key: 6597548
• MDR Text Key: 76200063
• Report Number: 3002807968-2017-00014
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K041874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2017

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: 393-801
• Device Catalogue Number: 393-801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 05/30/2017
• Supplement Dates Manufacturer Received: 08/24/2017
• Supplement Dates FDA Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2011
• 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