BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3792652 · Received May 6, 2014

    Report

    Report Number
    2531779-2014-12618
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Report Date
    April 25, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 12/30/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/17/2015 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS CRACKED. UNRELATED TO THE ORIGINAL COMPLAINT, RUST WAS OBSERVED INSIDE THE BATTERY COMPARTMENT. A LEAK TEST WAS PERFORMED AND FAILED DUE TO A BATTERY COMPARTMENT LEAK. THE PUMP WAS OPENED AND NO FURTHER EVIDENCE OF MOISTURE WAS FOUND INTERNALLY. THE DISPLAY WAS DIM AND DISCOLORED. THE AUDIO BOLUS BUTTON COVER WAS DAMAGED; HOWEVER THE AUDIO BOLUS BUTTON WAS RESPONSIVE TO USER PRESSES. THE CONTRAST AND OK BUTTONS WERE INTERMITTENTLY RESPONSIVE. UPON REMOVAL OF THE KEYPAD COVER, CONTAMINATION WAS FOUND UNDER ALL CONTACTS. 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.

    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 MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE BATTERY COMPARTMENT WAS CRACKED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270299 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR