BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY ALKALINE PHOSPHATASE REAGENT

    MDR report key: 2246990 · Received September 13, 2011

    Report

    Report Number
    1628664-2011-00611
    Event Type
    Malfunction
    Date Received
    September 13, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 16, 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

    NO CONSEQUENCES OR IMPACT TO PATIENT. CONTAMINATION DURING USE. 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 OBSERVED HIGH ABSORBANCE VALUES FOR CALIBRATION OF THE CLINICAL CHEMISTRY ALKALINE PHOSPHATASE ASSAY SINCE THE FIRST USE OF REAGENT LOT 08145UN11 ON (B)(6) 2011. THE CUSTOMER STATED QUALITY CONTROLS WERE UNAFFECTED AND NO CALIBRATION FAILURES OR PATIENT EXCEPTIONS WERE OBSERVED. THE CUSTOMER DID OBSERVE BLOCK SPOTS INSIDE THE ALKALINE PHOSPHATASE REAGENT CARTRIDGES AND PERFORMED MICROSCOPY. THE CUSTOMER DETERMINED THE REAGENT'S DARK COLOR WAS THE RESULT OF FUNGAL ELEMENTS PRESENT IN THE REAGENT AND REQUESTED REPLACEMENT REAGENTS. 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 08145UN11

    Patients

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