BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3931015 · Received July 13, 2014

    Report

    Report Number
    2531779-2014-19819
    Event Type
    Malfunction
    Date Received
    July 13, 2014
    Report Date
    July 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/11/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/29/2014 WITH THE FOLLOWING FINDINGS:DURING A VISUAL INSPECTION OF THE PUMP, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED WITH EVIDENCE OF MOISTURE INGRESS INSIDE. A LEAK TEST WAS PERFORMED AND CONFIRMED A BATTERY COMPARTMENT LEAK AS WELL AS A DISPLAY LENS LEAK. UNRELATED TO THE COMPLAINT, THE PUMP WAS POWERED ON AND THE DISPLAY SCREEN APPEARED DIM AND DISCOLORED. ADDITIONALLY, THE BOLUS BUTTON WAS INTERMITTENTLY UNRESPONSIVE. THE BOLUS BUTTON COVER WAS REMOVED, AND CORROSION DUE TO MOISTURE WAS FOUND ON THE BUTTON CONTACT.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (MOISTURE INGRESS) ISSUE. IT WAS REPORTED THAT MOISTURE WAS VISIBLE IN THE PUMP BATTERY COMPARTMENT. NO DAMAGE TO THE PUMP CASING WAS REPORTED. 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
    409068 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR