BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HGBPRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM

    MDR report key: 1994296 · Received January 14, 2011

    Report

    Report Number
    2248721-2011-00015
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 20, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GKR
    PMA / PMN Number
    K023561
    Removal / Correction Number
    RAF 10-026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE ARE TWO PATIENTS FOR THIS COMPLAINT. THIS REPORT IS FOR THE FIRST PATIENT. REFER TO 2248721-2011-00017 FOR THE REPORT FOR PATIENT 2. METHOD: DEVICE HISTORY RECORD, NCMR, CAPA AND COMPLAINT HISTORY EVALUATED. NO PRODUCT RETURNED. RESULTS: RECORD EVALUATION COMPLETED. COMPLAINT COULD NOT BE CONFIRMED. CONCLUSIONS: USER AND/OR DEVICE ERROR MAY HAVE CONTRIBUTED TO ALLEGED COMPLAINT. LOT STRIPS BEING RECALLED (B)(4) DUE TO HIGHER THAN SPECIFIED BIAS. THE FDA WAS NOTIFIED OF FIELD ACTION ON (B)(6) 2010. RECALL NUMBER HAS NOT BEEN ASSIGNED BY FDA. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    PATIENT 1 OF 2. HEALTHCARE PROFESSIONAL REPORTS HGBPRO "RESULTS NOT MATCHING THE LAB/HOSPITAL RESULTS". THE CUSTOMER COLLECTED THE SAMPLES USING A VENOUS DRAW WITH A PEDIATRIC EDTA (LAVENDER TOP) TEST TUBE AND TRANSFERRED THE SAMPLES TO THE STRIPS, AND SENT THE TUBE OUT FOR TESTING. CUSTOMER VERIFIED CORRECT STRIP LOT WAS ENTERED IN THE INSTRUMENT. CONTROLS WERE IN RANGE. ON (B)(6) 2010: HBG 9.5 G/DL ON HGBPRO; HGB 8.6 G/DL AT REFERENCE LAB. ON (B)(6) 2010: 10.3, 9.7, AND 9.8 G/DL ON HGBPRO; HGB 10.6 G/DL AT LOCAL HOSPITAL LAB DURING CBC. THE STRIPS ARE STORED AT ROOM TEMPERATURE. IT WAS NOTED THAT THE DESICCANT PACK WAS NO LONGER IN THE CONTAINER. THE CUSTOMER USED ONE TUBE OF TWENTY-FIVE STRIPS IN ABOUT THREE MONTHS. IT WAS ALSO NOTED THAT THE INSTRUMENT WAS DROPPED A "WHILE BACK" AND WAS NOT SURE IF THAT WOULD HAVE ANY EFFECT ON THE RESULTS. ACCORDING TO THE REPORTER THE DIFFERENCE IN THE RESULTS GENERATED ARE ABOUT 9-10%. THE CUSTOMER DOES NOT FEEL THAT THE INSTRUMENT IS MALFUNCTIONING AND DOES NOT WISH TO RETURN THE INSTRUMENT. THE STORAGE REQUIREMENTS FOR HGB STRIPS ARE REQUIRED TO BE STORED WITH THE DESICCANT. NO ADVERSE EVENT(S) REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HGBPRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM GKR INTERNATIONAL TECHNIDYNE CORP. HGBTEST100 F9HGS0051

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO