BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2193378 · Received August 5, 2011

    Report

    Report Number
    2531779-2011-05642
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. 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 (B)(4) 2011-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED AND CORROSION WAS FOUND IN THE BATTERY COMPARTMENT. A REVIEW OF THE BLACK BOX HISTORY SHOWED NO POWER RESET EVENTS. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT POWER LOSS. THE PUMP WAS LEAK TESTED AND FOUND TO BE LEAKING FROM THE BATTERY COMPARTMENT AND THE DISPLAY LENS. UNRELATED TO THE COMPLAINT, THE KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO BUTTON PRESSES AND CONTAMINATION WAS FOUND UNDER THE BUTTON CONTACTS. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PUMP LOST POWER OVER NIGHT AFTER SHE WENT SWIMMING IN (B)(6). SHE REPORTED THAT SOME WATER HAD LEAKED INTO THE BATTERY COMPARTMENT AND THERE WAS CORROSION PRESENT. THE PATIENT REPORTEDLY CONTINUED ON THE PUMP AS IT WAS ABLE TO POWER ON. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PUMP LOST POWER.

    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 27 YR