BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C CREATININE

    MDR report key: 10181512 · Received June 22, 2020

    Report

    Report Number
    3002809144-2020-00493
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Date of Event
    May 14, 2020
    Report Date
    July 7, 2020
    Manufacturer
    ABBOTT GMBH
    Product Code
    CGX
    UDI-DI
    00380740135119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF TICKETS DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR ALINITY CREATININE LN 7P99 LOT 82385UN19. TRENDING REVIEW DETERMINED NO TRENDS FOR FALSELY ELEVATED RESULTS FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY CREATININE LN 7P99 LOT 82385UN19 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSELY ELEVATED CREATININE RESULT GENERATED ON THE ALINITY C ANALYZER ON ONE PATIENT. RESULTS PROVIDED: (B)(6) 2020, SID (B)(6) = 428 UMOL/L, REPEATED ON ANOTHER ALINITY C ON (B)(6) 2020 = 83 UMOL/L. REFERENCE RANGE: MALE (63.6 - 110.5 UMOL / L) FEMALE (50.4 - 98.1 UMOL / L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645593 ALINITY C CREATININE CREATININE CGX ABBOTT GMBH 07P9930 82385UN19 00380740135119

    Patients

    Seq Age Sex Outcome Treatment
    1 ALINITY C PROCESSING MODULE LIST 03R67-01| ALINITY C PROCESSING MODULE LIST 03R67-01| SERIAL (B)(6)| SERIAL (B)(6)