BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C CREATININE REAGENT KIT

    MDR report key: 11666939 · Received April 14, 2021

    Report

    Report Number
    3002809144-2021-00253
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 25, 2021
    Report Date
    May 24, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    CGX
    UDI-DI
    00380740135119
    PMA / PMN Number
    K083809
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF TICKETS DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR REAGENT LOT 09740UN20. TRENDING REVIEW IDENTIFIED NO TRENDS FOR ELEVATED RESULTS FOR THE ALINITY C CREATININE ASSAY. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS RELATED TO THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE ISSUE APPEARS TO BE SAMPLE SPECIFIC FOR CERTAIN PATIENT SAMPLES. THE SAMPLE WAS REPEATED TWICE ON TWO DIFFERENT ANALYZERS AND AN ACCEPTABLE RESULT WAS GENERATED. QUALITY CONTROL RESULTS WERE WITHIN RANGE AT THE TIME OF THE INCIDENT. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF ALINITY C CREATININE, LOT 09740UN20 WAS IDENTIFIED.THIS FOLLOW UP IS BEING SUBMITTED TO INCLUDE D8 AND H6 INFORMATION PREVIOUSLY SUBMITTED USING THE H10 SECTION IN THEIR RESPECTIVE FIELDS.

    Description of Event or Problem · 0

    THE CUSTOMER OBTAINED A FALSELY ELEVATED ALINITY C CREATININE RESULT. SAMPLE ID(B)(6) GENERATED AN INITIAL RESULT OF 660.87 UMOL/L AND RETEST OF 82.30 UMOL/L. DUE TO THE ELEVATED RESULT THE PATIENT WENT TO THE A&E AND HAD BLOOD TESTS. NO FURTHER IMPACT WAS REPORTED. DUE TO THE ELEVATED RESULT THE PATIENT WENT TO THE A&E AND HAD BLOOD TESTS. NO FURTHER IMPACT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. PATIENT INFORMATION: NO FURTHER INFORMATION WAS PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A FALSELY ELEVATED ALINITY C CREATININE RESULT. SAMPLE ID (B)(6) GENERATED AN INITIAL RESULT OF 660.87 UMOL/L AND RETEST OF 82.30 UMOL/L. DUE TO THE ELEVATED RESULT THE PATIENT WENT TO THE A&E AND HAD BLOOD TESTS. NO FURTHER IMPACT WAS REPORTED. DUE TO THE ELEVATED RESULT THE PATIENT WENT TO THE A&E AND HAD BLOOD TESTS. NO ADVERSE IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562184 ALINITY C CREATININE REAGENT KIT ALKALINE PICRATE, COLORIMETRY, CREATININE CGX ABBOTT GMBH 07P9930 09740UN20 00380740135119

    Patients

    Seq Age Sex Outcome Treatment
    1 ALNTY C PROCESSING MODU, 03R67-01, AC02032| ALNTY C PROCESSING MODU, 03R67-01, AC02032