BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2092977 · Received May 18, 2011

    Report

    Report Number
    2531779-2011-03519
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    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 # 2 DATE OF SUBMISSION (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY DID NOT INDICATE ANY POWER ISSUES. THE PUMP HISTORY INDICATED THAT THE PUMP WAS IN USE UNTIL (B)(6) 2011; THERE WAS NO DATA AVAILABLE IN THE PUMP HISTORY FROM THE TIME OF THE COMPLAINT DUE TO CONTINUED PUMP USE. THERE WAS NO DAMAGE FOUND TO THE BATTERY CAP AND COMPARTMENT. THE BATTERY CAP WAS ABLE TO SECURE APPROPRIATELY DURING TESTING. THERE WAS NO DAMAGE FOUND TO THE POWER CIRCUIT. THE PUMP POWERS ON NORMALLY WITH NO ALARMS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OCCURRING. THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED ON INVESTIGATION.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PUMP HAS LOST POWER 4 TIMES IN (B)(6), AND THAT THE DATE AND TIME ARE NOT CORRECT WHEN POWER LOSS OCCURS. NO FURTHER INFORMATION WAS PROVIDED, AND THE PUMP IS NOT BEING RETURNED AT THIS TIME; THERE HAVE BEEN NO FURTHER REPORTED INCIDENTS. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION OF POWER LOSS.

    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 5 YR