BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3211865 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09902
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE NOT YET BEEN RETURNED. IF THE PRODUCT(S) ARE RETURNED, ANM WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/15/2013 WITH THE FOLLOWING FINDINGS: INVESTIGATION WAS UNABLE TO DUPLICATE THE REPORTED BLANK DISPLAY; INVESTIGATION REVEALED A DIM AND FADED DISPLAY SCREEN. A NEW TEST SCREEN WAS INSERTED AND THE DISPLAY ILLUMINATED TO NORMAL CONTRAST. UNRELATED TO THE COMPLAINT, THE KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONSIVE AND MULTIPLE BUTTON PRESSES WERE REQUIRED TO RESPOND. A HOLE WAS NOTED ON THE BOLUS BUTTON; THE BOLUS BUTTON WAS FOUND TO BE RESPONSIVE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY ISSUE INVOLVING A BLANK SCREEN. THE REPORTER STATED THE DISPLAY WAS BLANK WHEN HE WOKE UP ON THE DAY OF THE COMPLAINT AND WOULD NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309375 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR