BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2161487 · Received July 14, 2011

    Report

    Report Number
    2531779-2011-04931
    Event Type
    Injury
    Date Received
    July 14, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    FOLLOW-UP #1 (B)(4) 2011-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED AND CORROSION WAS PRESENT IN THE BATTERY COMPARTMENT. THE BATTERY CAP SECURED TO THE PUMP BUT THE YELLOW-O-RING REMAINED VISIBLE. THE PUMP BOOTED TO THE "VERIFY" SCREEN WITH APPROPRIATE ALARMS. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT POWER ISSUES. THE PUMP WAS OPENED AND NO DAMAGE WAS OBSERVED TO THE PCB. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO HAVE A RED TINT. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE EXPERIENCED A BLOOD GLUCOSE (BG) OF HIGH (ABOVE 600MG/DL) ON THE METER WITH NO SIGNS OR SYMPTOMS. THE PATIENT REPORTED THAT THE PUMP SHUT OFF AND SHE WAS NOT GETTING INSULIN FOR A PERIOD OF TIME THE NIGHT THAT SHE CALLED CUSTOMER SUPPORT. SHE REPORTEDLY PRESSED THE BUTTON AND THE SCREEN WOULD NOT TURN ON. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S HYPERGLYCEMIC EVENT WHILE ON INSULIN PUMP THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention