BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY CREATININE

    MDR report key: 3727739 · Received April 4, 2014

    Report

    Report Number
    1628664-2014-00067
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 25, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CGX
    PMA / PMN Number
    K981799
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE CLINICAL CHEMISTRY CREATININE ASSAY PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. A REVIEW OF THE INFORMATION FROM THE CUSTOMER SITE FOUND THAT THE CUSTOMER BELIEVES THAT A SAMPLE MIX-UP ON THEIR PART MAY HAVE CAUSED THE COMPLAINT ISSUE; HOWEVER, ALL SAMPLE HAD BEEN DISCARDED BEFORE THIS COULD BE VERIFIED. ALSO, THE LAB PROTOCOL FOR SAMPLE CENTRIFUGATION IS SET AT 4000 RCF FOR 10 MINUTES, WHICH IS NOT CONSISTENT WITH THE SAMPLE TUBE MANUFACTURER'S RECOMMENDATIONS. THE CUSTOMER WAS INFORMED TO FOLLOW THE SAMPLE PREPARATION REQUIREMENTS PER THE TUBE MANUFACTURERS SPECIFICATIONS. BASED ON THE RESULTS OF THE CURRENT PRODUCT EVALUATION AND THE INFORMATION FROM THE CUSTOMER SITE, IT WAS DETERMINED THAT THE ARCHITECT CLINICAL CHEMISTRY CREATININE ASSAY, LIST NUMBER 03L81-22, LOT NUMBER 67865UN13 IS PERFORMING AS EXPECTED. A PRODUCT MALFUNCTION WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS DISCREPANT CLINICAL CHEMISTRY CREATININE ASSAY RESULTS FOR ONE PATIENT SERUM SAMPLE TESTED ON AN ARCHITECT C4000 ANALYZER. AN INITIAL RESULT OF OVER 200 UMOL/L WAS GENERATED (AN EXACT RESULT WAS NOT PROVIDED BY THE CUSTOMER). THE SAMPLE WAS THEN RETESTED WITH RESULTS OF 60 AND 200 UMOL/L. THE CUSTOMER PROVIDED THE FOLLOWING CREATININE RESULTS FOR THIS PATIENT:(B)(6) 2014: 215.60 UMOL/L;(B)(6) 2014: 173.10 UMOL/L;(B)(6) 2014: 60.10 UMOL/L WITH A URIC ACID RESULT OF 0.35 MMOL/L; AND,(B)(6) 2014: INITIAL RUN AT 221.90 UMOL/L, RETEST AT 226.40 UMOL/L WITH A URIC ACID RESULT OF 0.67 MMOL/L.CONTROLS HAVE BEEN WITHIN SPECIFICATIONS. A SERVICE CALL WAS INITIATED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.THE CUSTOMER LATER REPORTED THAT THERE IS THE POSSIBILITY OF A SAMPLE BEING SWITCHED DURING THEIR SAMPLE HANDLING PROCESS, BUT SINCE ALL SAMPLES HAVE SINCE BEEN DISCARDED, THEY CANNOT VERIFY IF THIS INDEED CAUSED THE COMPLAINT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203619 CLINICAL CHEMISTRY CREATININE CREATININE CGX ABBOTT MANUFACTURING INC 67865UN13

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C4000 LN:02P24-40 SN:(B)(4)| ARCHITECT C4000 LN:02P24-40 SN:(B)(4)