BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAP-8E

    MDR report key: 5392697 · Received January 27, 2016

    Report

    Report Number
    5392697
    Event Type
    Malfunction
    Date Received
    January 27, 2016
    Date of Event
    December 17, 2015
    Report Date
    January 11, 2016
    Manufacturer
    BIO/DATA CORP.
    Product Code
    JBX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE LABORATORY WAS PERFORMING A RISTOCETIN COFACTOR ACTIVITY ASSAY AND HAD SOME ISSUES WITH QUALITY CONTROL. THE STAFF MEMBER INADVERTENTLY DISCOVERED AN ERROR IN THE PACKAGE INSERT INVOLVING HOW TO MAKE UP THE BLANK. THE ADJUSTMENT FACTOR WAS LISTED AS 1.5 AND SHOULD HAVE BEEN 1.0. WE CONTACTED THE VENDOR, BIO/DATA CORPORATION AND THEY STATED THE CORRECTION FACTOR WAS INCORRECT. WE CEASED PERFORMANCE OF THIS TEST. MANUFACTURER RESPONSE FOR BIO/DATA PAP-8E, PAP (PER SITE REPORTER): THE VENDOR CONFIRMED THE ADJUSTMENT FACTOR WAS INCORRECT IN THEIR REAGENT PACKAGE INSERT. THEY ARE ISSUING A REVISION TO THE PACKAGE INSERT AND WILL REPLACE REAGENT USED DURING WHAT WE THOUGHT WERE ASSAY ISSUES AND DURING OUR INVESTIGATION OF THE ISSUE. VENDOR STATED THE FOLLOWING IN AN E-MAIL: THE KITS WE RECEIVED WERE FROM A SINGLE, SMALL BATCH, ALL OF WHICH WAS SHIPPED TO US. SINCE THE ADJUSTMENT FACTOR WAS A CONSTANT THROUGHOUT TESTING, ITS EFFECT WAS LIMITED TO SHIFTING THE CURVE. THE NORMAL-ABNORMAL BREAKPOINT WASN'T AFFECTED. THE % ACTIVITY WOULD BE SOMEWHAT DIFFERENT, BUT GIVEN THE NATURE OF THE ASSAY, THOSE DIFFERENCES SHOULD NOT HAVE AFFECTED CLINICAL DECISIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53112 PAP-8E AGGREGROMETER, PLATELET JBX BIO/DATA CORP. 8-E 34300053

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR NO