BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2213056 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05924
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY DID NOT SHOW ANY POWER ISSUES. THERE WAS NO DAMAGE NOTED TO THE BATTERY CAP AND COMPARTMENT; THE BATTERY CAP WAS ABLE TO FASTEN SECURELY TO THE PUMP. THE PUMP BOOTED UP TO THE VERIFICATION SCREEN WITH FUNCTIONAL AUDITORY AND VIBRATORY ALARMS. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO POWER ISSUES OCCURRING. THERE WAS NO DEFECT FOUND ON INVESTIGATION; THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ALLEGING THAT HER PUMP WOULD NOT POWER ON. AT THE TIME OF TROUBLESHOOTING, THE PATIENT CONFIRMED SHE REPLACED THE PUMP'S BATTERY; HOWEVER, POWER ISSUE REMAINED UNRESOLVED. THE PATIENT REPORTED NO VISIBLE DAMAGE TO BATTERY COMPARTMENT OR BATTERY CAP. IN ADDITION, THE PATIENT DENIED ANY CORROSION WITHIN BATTERY COMPARTMENT. PRIOR TO WHEN POWER ISSUE WAS DISCOVERED, THE PATIENT REPORTED SHE HAD BEEN OFF THE PUMP FOR APPROXIMATELY 1 WEEK. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR