BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY LACTATE DEHYDROGENASE

    MDR report key: 7118419 · Received December 14, 2017

    Report

    Report Number
    1628664-2017-00515
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    November 14, 2017
    Report Date
    January 26, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CFJ
    UDI-DI
    00380740000509
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER EVALUATION OF THE CUSTOMER ISSUE, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT C8000 SYSTEM TO CLINICAL CHEMISTRY LACTATE DEHYDROGENASE REAGENT ON (B)(6) 2018. SUSPECT MEDICAL DEVICE WAS UPDATED ACCORDINGLY. NO CUSTOMER RETURNS WERE AVAILABLE. INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS AND A REVIEW OF LABELING. HISTORICAL QUALITY METRICS WERE REVIEWED AND NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. COMPLAINT SEARCHES DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT. INSTRUMENT LOGS WERE PULLED FROM ABBOTTLINK AND REVIEWED FOR THE TIME OF RESULTS INDICATED BY THE CUSTOMER. THERE WERE 18 OCCURRENCES OF ERROR CODE 3375 (UNABLE TO PROCESS TEST, ASPIRATION ERROR OCCURRED.). FREQUENT OCCURRENCES OF THIS ERROR CODE OR OCCURRENCES WITH NO ASSIGNABLE CAUSE MAY INDICATE INADEQUATE CENTRIFUGATION OR SAMPLE PREPARATION. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    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 OBSERVED LDH IMPRECISION ON THE ARCHITECT C8000 SYSTEM, SERIAL NUMBER (B)(4). THE FOLLOWING DATA WAS PROVIDED. PATIENT (B)(6): RESULT OF 217 U/L ON SERIAL NUMBER (B)(4) AND 212 / 281 U/L ON SERIAL NUMBER (B)(4). THE CUSTOMER BELIEVES THE RESULT OF 281 U/L IS INCORRECT. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895793 CLINICAL CHEMISTRY LACTATE DEHYDROGENASE LACTATE DEHYDROGENASE CFJ ABBOTT MANUFACTURING INC 34631UN17 00380740000509

    Patients

    Seq Age Sex Outcome Treatment
    1