BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACTIN FSL

    MDR report key: 1258190 · Received November 26, 2008

    Report

    Report Number
    9610806-2008-00006
    Event Type
    Other
    Date Received
    November 26, 2008
    Date of Event
    November 15, 2008
    Report Date
    November 15, 2008
    Manufacturer
    DADE BEHRING GMBH
    Product Code
    JPA
    PMA / PMN Number
    K863594
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED APTT RESULT WAS USER ERROR. RESULTS WITH ERR 128, ERE 18 SHOULD NOT BE REPORTED. THE CA SERIES MEASUREMENT EVALUATION AND CHECKING METHOD (FOR CUSTOMER USE) STATES: DO NOT REPORT ANY RESULT WITH AN "EARLY REACTION ERROR" WITHOUT REVIEWING THE CURVE. ONLY ERE CODE 1 (CA-1500 OR CA-7000) OR ERE CODE 4 MAY BE REPORTED AFTER VISUAL INSPECTION OF THE REACTION CURVE. AN APTT RESULT < 20 SECONDS SHOULD NOT BE REPORTED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED APTT RESULT WITH AN ERROR 128 WITH ERE 18 FLAG WAS OBTAINED ON A PT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE ORIGINAL SAMPLE WAS RETESTED AND HIGHER RESULTS WERE OBTAINED. THE PT RECEIVED A BOLUS OF HEPARIN. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED APTT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIN FSL APTT REAGENT JPA DADE BEHRING GMBH NA 537304

    Patients

    Seq Age Sex Outcome Treatment
    1