BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2181885 · Received July 28, 2011

    Report

    Report Number
    2531779-2011-05382
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP POWERS ON NORMALLY WITH NO ALARMS. THERE WAS NO DAMAGE NOTED TO THE BATTERY CAP AND COMPARTMENT; THE BATTERY CAP WAS ABLE TO ATTACH SECURELY TO THE PUMP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OCCURRING. EVALUATION REVEALED VISIBLE MOISTURE IN THE DISPLAY LENS, A CASE LEAK, AND MOISTURE DAMAGE INSIDE THE PUMP.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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

    THE PATIENT CONTACTED ANIMAS ALLEGING THAT HIS PUMP WOULD NOT POWER ON AFTER RECEIVING A CALL SERVICE ALARM. AT THE TIME OF TROUBLESHOOTING THE PATIENT CONFIRMED THERE WAS NO VISIBLE CORROSION IN THE BATTERY COMPARTMENT OR VISIBLE STRUCTURAL DAMAGE TO ON THE BATTERY CAP OR BATTERY COMPARTMENT. THE PATIENT INSERTED A NEW ALKALINE BATTERY INTO THE PUMP; HOWEVER, CLAIMED IT STILL DID NOT POWER ON. THERE WAS NO REPORTED PATIENT IMPACT WITH THIS COMPLAINT.

    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 34 YR