BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1911880 · Received November 24, 2010

    Report

    Report Number
    2531779-2010-02504
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    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: VISUAL INSPECTION REVEALED A CRACKED BATTERY COMPARTMENT AND STRIPPED THREADS ON THE BATTERY CAP. THE BATTERY CAP WAS UNABLE TO MAINTAIN AN ELECTRICAL CONNECTION, AND POWER LOSS AND REBOOTING WAS DUPLICATED. A TEST BATTERY CAP WAS USED TO COMPLETE TESTING. THE PUMP POWERED ON NORMALLY WITH NO ALARMS. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO ISSUES OCCURRING; NO FURTHER POWER ISSUES OCCURRED DURING TESTING.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE PUMP LOSES POWER ABOUT ONCE PER MONTH. SHE STATED THAT THE POWER ISSUE IS NOT ASSOCIATED WITH LOW BATTERY WARNING OR REPLACE BATTERY ALARM; SHE REPLACES THE BATTERY AND THE ISSUE IS RESOLVED FOR ANOTHER MONTH. THE PT NOTED THAT THE BATTERY CAP WAS ALWAYS SECURE AT THE TIME OF ISSUES, THE CAP IS INTACT AND THE BATTERY COMPARTMENT IS NOT CRACKED. CONCURRENTLY, THE PT REPORTED THAT SHE EXPERIENCED ELEVATED BLOOD GLUCOSE READINGS (300 MG/DL TO 400 MG/DL) SPORADICALLY FOR ABOUT TWO MONTHS SINCE (B)(6). SHE NOTED THAT THE ISSUES BEGAN WITH NEW SHIPMENT OF INSULIN. IN ADDITION, SHE EXPLAINED THAT SHE IS PREMENOPAUSAL. SHE REVIEWED THE PUMP AND SAID THAT THE TIME IS OFF BY 30 MINUTES. SHE STATED THAT SHE KNEW THE TIME WAS INCORRECT AND JUST IGNORED IT. ALL OTHER SETTINGS WERE CORRECT AND BASAL/BOLUS HISTORIES INDICATE THAT INSULIN DELIVERY WAS ACCURATE. THERE WERE NO ASSOCIATED ALARMS IN THE HISTORY. SHE DENIED ISSUES AT INFUSION SITE; SHE DENIED BUBBLES OR INSULIN LEAKS. AUDIBLE TONES AND VIBRATION FEATURE FUNCTIONED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR