BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2142077 · Received June 28, 2011

    Report

    Report Number
    2531779-2011-04516
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED A DAMAGED FORCE SENSOR FLEX WIRE. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH WAS DUPLICATED DURING TESTING. DURING TESTING THE LOAD STEP FAILED TO RECOGNIZE THE CARTRIDGE AND DISPENSED FLUID EMITTING A "NO CARTRIDGE DETECTED" WARNING. UNRELATED TO THIS COMPLAINT, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THE USER GUIDE INSTRUCTS THE PATIENT THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PUMP HAS BEEN EMPTYING THE CARTRIDGE AT THE LOAD STEP EACH TIME A CARTRIDGE CHANGE HAS BEEN ATTEMPTED SINCE (B)(6) 2011.

    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 8 YR