BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR

    MDR report key: 2193348 · Received July 28, 2011

    Report

    Report Number
    1826988-2011-00441
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 9, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE ANY PRODUCT INFO. IT'S NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE OR 510(K) NUMBER WITHOUT THE METER INFO. THE CUSTOMER'S USB CABLE WAS RETURNED AND THE CASE CONTAINING THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) WAS VERIFIED TO HAVE BEEN MELTED. THE CABLE WAS TESTED WITH 3 DIFFERENT METERS AND CONNECTED TO A COMPUTER OVER A 30 MINUTE TIME PERIOD. THE CABLE WORKED CORRECTLY AND DOWNLOADED ALL 3 METERS. THE CABLE DID NOT GET HOT DURING THE 30 MINUTES. THE CASE AROUND THE PCBA WAS CUT OPEN. THERE WERE SIGNS OF OVERHEATING. SOME COMPONENTS MELTED OR CAME OFF THE BOARD, WHICH CAUSED THE PLASTIC HOUSING TO MELT. THE CABLE IS TO BE RETURNED TO THE SUPPLIER FOR FURTHER EVAL.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) CONTACTED CUSTOMER SVC. HE INSTALLED THE GLUCOFACTS SOFTWARE ON HIS COMPUTER AND THEN CONNECTED HIS CONTOUR METER USING A BAYER USB CABLE. THE SOFTWARE DID NOT APPEAR TO DETECT THE METER, SO THE CUSTOMER CHECKED THE CABLE CONNECTION. WHEN HE TOUCHED THE CABLE, IT WAS VERY HOT AND THE JUNCTION BOX ON THE CABLE HAD MELTED SLIGHTLY. THE CUSTOMER STATED HIS CARPET WAS SLIGHTLY BURNT AND HE ALSO REC'D A BLISTERING BURN ON HIS HAND. THE CABLE WAS RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE, LLC NOT PROVIDED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK