BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2935689 · Received January 30, 2013

    Report

    Report Number
    2531779-2013-01365
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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

    FOLLOW-UP #1 DATE OF SUBMISSION 09/15/2015-DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/27/2015 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, ALL THE KEYPAD BUTTON SYMBOLS WERE OBSERVED TO BE FADING. THE UP AND CONTRAST BUTTONS WERE UNRESPONSIVE TO USER PRESSES. WHEN THE KEYPAD WAS REMOVED THERE WAS CONTAMINATION PRESENT UNDER ALL THE BUTTON CONTACTS. UNRELATED TO THE ORIGINAL COMPLAINT, IT WAS OBSERVED THAT WHEN THE PUMP WAS POWERED ON, THE DISPLAY WAS DIM AND DISCOLORED. IT WAS ALSO OBSERVED THAT THERE WAS A CRACK IN THE BATTERY COMPARTMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING THE OK KEYPAD BUTTON WAS INTERMITTENTLY UNRESPONSIVE. 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
    41572 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR