BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3223056 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10483
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    July 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE NOT YET BEEN RETURNED. IF THE PRODUCT(S) ARE RETURNED, ANM WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 09/19/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/30/2013 WITH THE FOLLOWING FINDINGS:DURING EVALUATION, THE PUMP POWERED ON WITH A DIM AND DISCOLORED DISPLAY SCREEN. A TEST SCREEN WAS INSTALLED AND DISPLAYED NORMALLY. UNRELATED TO THE COMPLAINT, THE CONTRAST KEYPAD BUTTON WAS INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE PRESSES WITH INCREASED FORCE TO ELICIT A RESPONSE; ALL OTHER KEYPAD BUTTONS RESPONDED APPROPRIATELY. THE KEYPAD COVER HAD BEEN RETURNED INTACT; WHEN THE COVER WAS OPENED, EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS. ADDITIONALLY, EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DIM/FADING DISPLAY ISSUE. THE ISSUE BEGAN APPROXIMATELY ONE YEAR PRIOR TO THE COMPLAINT AND HAS GRADUALLY GOTTEN WORSE OVER TIME. 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
    324530 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR