BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3131767 · Received May 29, 2013

    Report

    Report Number
    2531779-2013-07137
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 07/29/2013 -DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP WOULD NOT POWER ON. THERE WAS VISIBLE MOISTURE IN THE DISPLAY. THE PUMP FAILED LEAK TESTING WITH A DISPLAY LENS LEAK. THERE WERE NO CRACKS FOUND IN THE PUMP CASING. THE PUMP COVER WAS REMOVED AND THERE WAS CORROSION OBSERVED ON THE BOTTOM PORTION OF THE PUMP AND CASE. THE FORCE SENSOR AND POWER CIRCUITS WERE CORRODED. THERE WAS NO CORROSION FOUND IN THE BATTERY COMPARTMENT. ADDITIONAL TESTING COULD NOT BE COMPLETED DUE TO THE PUMP NOT POWERING ON.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE PUMP REPORTEDLY LOST POWER AFTER EXPOSURE TO WATER. THERE WAS REPORTEDLY NO DAMAGE TO THE PUMP. THE REPORTER ATTEMPTED TO POWER ON THE PUMP WITH MULTIPLE BATTERIES WITH NO SUCCESS. 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
    235380 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR