BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2073479 · Received May 1, 2011

    Report

    Report Number
    2531779-2011-03006
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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: INVESTIGATORS WERE UNABLE TO FULLY INVESTIGATE, AS THE PUMP WOULD NOT POWER ON. A LEAK TEST WAS PERFORMED, AND A KEYPAD LEAK WAS OBSERVED. THERE WAS EVIDENCE OF CORROSION FOUND ON THE PRINTED CIRCUIT BOARD. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THE PUMP WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ALLEGING THE PUMP HAD NO POWER. THE PATIENT REPORTED THAT ON (B)(6) 2011 SHE WORE PUMP INTO A SWIMMING POOL. WHILE DRIVING HOME, SHE HEARD THE PUMP BEEPING; HOWEVER, THE SCREEN WAS BLANK. AT A LATER TIME THAT DAY, SHE REPORTED THERE WAS NO POWER TO PUMP. THERE WAS NO MENTION OF SYMPTOMS OR MEDICAL TREATMENT REQUIRED AS A RESULT OF THE ALLEGED POWER ISSUE. AT THE TIME OF TROUBLESHOOTING, THE PATIENT CLAIMED THE BATTERY CAP IS NEW AND THE SPRING, YELLOW O-RING, THREADS, AND METAL TABS ARE ALL IN PLACE. THE PATIENT CONFIRMED THERE WAS NO MOISTURE IN BATTERY COMPARTMENT OR UNDER THE SCREEN. THE PATIENT REPLACED THE BATTERY; HOWEVER, THE PUMP DID NOT POWER ON. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED POWER ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 1250 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1