BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2781325 · Received October 10, 2012

    Report

    Report Number
    2531779-2012-12116
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Report Date
    September 12, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILLED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2012-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH VISIBLE MOISTURE IN THE DISPLAY LENS. THE PUMP DOES NOT POWER ON. LEAK TESTING REVEALED A CASE SEAL LEAK, AND A SMALL CRACK BETWEEN THE DISPLAY LENS AND THE CASE SEAL WAS OBSERVED. THE PUMP COVER WAS REMOVED, AND THERE WAS INTERNAL MOISTURE OBSERVED. FURTHER INVESTIGATION COULD NOT BE COMPLETED DUE TO INABILITY TO POWER ON THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS, ALLEGING THE PUMP DID NOT POWER ON. AT THE TIME OF TROUBLESHOOTING, THE PATIENT DENIED ANY VISIBLE DAMAGE TO THE PUMP'S BATTERY COMPARTMENT OR BATTERY CAP. IN ADDITION, THE PATIENT DENIED ANY EVIDENCE OF MOISTURE INGRESS. 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
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR