BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2091797 · Received May 17, 2011

    Report

    Report Number
    2531779-2011-03492
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 23, 2011
    Report Date
    April 24, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 (B)(6) 2011. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS. 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

    FOLLOW-UP # 1 (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE BATTERY CAP WAS FOUND TO BE VISIBLY DAMAGED AND WOULD NOT FULLY TIGHTEN TO THE PUMP. A TEST CAP WAS USED AND THE PUMP WAS ABLE TO POWER ON PROPERLY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO RE-BOOTS OCCURRING. THE USER GUIDE INSTRUCTS THE PATIENT TO REPLACE THE BATTERY CAP AT LEAST ONCE PER YEAR AND THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP. UNRELATED TO THE COMPLAINT, THE KEYPAD WAS FOUND TO BE TORN AT THE OK BUTTON AND CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    ON (B)(6) 2011 IT WAS REPORTED THE INSULIN PUMP WAS POWERED OFF AFTER BEING EXPOSED TO WATER IN A SWIMMING POOL. THE PATIENT DID NOT REPORT EXPERIENCING ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS, AND DENIED SEEKING MEDICAL ATTENTION. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE.

    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