BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY ALKALINE PHOSPHATASE REAGENT

    MDR report key: 2246077 · Received September 13, 2011

    Report

    Report Number
    1628664-2011-00608
    Event Type
    Malfunction
    Date Received
    September 13, 2011
    Report Date
    August 8, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CJE
    PMA / PMN Number
    K981806
    Removal / Correction Number
    1628664-8/29/11-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT: NO CONSEQUENCES OR IMPACT TO PATIENT (B)(6); (B)(4) DEVICE: CONTAMINATION DURING USE (B)(4). THE CAUSE OF THE CLINICAL CHEMISTRY ALKALINE PHOSPHATASE REAGENTS FAILED TO CALIBRATE/GENERATE RESULTS WAS DUE TO VISIBLE PARTICULATE OR VISIBLE MOLD IN THE REAGENT CARTRIDGES. ABBOTT ISSUED A PRODUCT RECALL LETTER TO ALL CUSTOMERS TO INFORM THEM TO DISCONTINUE USE AND TO DISCARD/DESTROY ANY SUSPECT CARTRIDGES AND ORDER REPLACEMENT REAGENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONFIRMED THERE WAS AN INCREASE OF PATIENT EXCEPTIONS ON READS WERE THE ABSORBANCE WAS TOO HIGH WHILE CLINICAL CHEMISTRY ALKALINE PHOSPHATASE REAGENT LOT 62474UN10 WAS IN USE, ALTHOUGH ASSAY MEANS, SD AND %CV WERE WITHIN THE LAB'S ACCEPTABLE LIMITS. THE CUSTOMER REJECTED CLINICAL CHEMISTRY ALKALINE PHOSPHATASE REAGENT LOT 62474UN10 DUE TO FUNGAL GROWTH FOUND IN RANDOM REAGENT CARTRIDGES. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY ALKALINE PHOSPHATASE REAGENT CJE ABBOTT MANUFACTURING INC 62474UN10

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C16000, LIST # 3L77-01, SERIAL # (B)(4)