BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2191397 · Received August 4, 2011

    Report

    Report Number
    2531779-2011-05600
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Report Date
    July 8, 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)(4). DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 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

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED EXPERIENCING A BLOOD GLUCOSE (BG) OF 365 MG/DL AFTER THE PUMP REBOOTED MULTIPLE TIMES. THERE WERE NO REPORTED SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE REPORTED BG EXCURSION DOES NOT MEET THE DEFINITION OF A SERIOUS INJURY. THE PATIENT REPORTED THAT SHE WAS TIGHTENING THE BATTERY CAP WITH HER FINGERNAIL. SHE STATED THAT THE PUMP WOULD GO TO THE VERIFY SCREEN AND THEN SHUT OFF. THE PATIENT STATED THAT THE BATTERY CAP WAS SECURED TO THE PUMP, AND THE O-RING WAS NOT VISIBLE. THE PATIENT CONFIRMED THAT THERE WAS NO STRUCTURAL DAMAGE TO THE BATTERY CAP AND COMPARTMENT. THE PATIENT NOTED THAT THE BATTERY CAP HAD NEVER BEEN CHANGED. CUSTOMER SUPPORT INSTRUCTED THE PATIENT THAT THE BATTERY CAP SHOULD BE CHANGED EVERY SIX MONTHS. THE PATIENT WAS INSTRUCTED TO INSERT A NEW BATTERY, AND STATED THAT THE ISSUE WAS RESOLVED WITH INSERTION OF A NEW BATTERY. THE PUMP IS NOT BEING RETURNED AT THIS TIME. THE PATIENT RESUMED INSULIN PUMP THERAPY WITHOUT FURTHER REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 1250 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR