BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2220815 · Received August 23, 2011

    Report

    Report Number
    2531779-2011-06139
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP WAS RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012: NO DEFECT WAS FOUND. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED BASAL RATES. NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN BLACK BOX OR DOWNLOAD HISTORY. NO DATA IN BLACK BOX OR DOWNLOAD HISTORIES FROM TIME OF THE REPORTED LOW BLOOD GLUCOSE LEVELS, DUE TO CONTINUED USE.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY HOSPITALIZED ON (B)(6) 2011 WITH A BLOOD GLUCOSE OF 0.9 MMOL/L. THE PATIENT'S SITE HAD REPORTEDLY FALLEN OUT AT 04:00 ON (B)(6) 2011 AND THE PATIENT WAS TREATED WITH A BACK UP TREATMENT PLAN DUE TO RUNNING OUT OF SUPPLIES. THE PATIENT WAS REPORTEDLY GIVEN AN INJECTION AS SUGGESTED BY THE PUMP EZBG CALCULATION. AT 08:30 THE PATIENT WAS REPORTEDLY UNABLE TO WAKE UP AND AN AMBULANCE WAS CALLED. THE PATIENT REPORTEDLY RESUMED THE PUMP AND THERE HAVE BEEN NO FURTHER ISSUES AT THIS TIME.

    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 28 YR Hospitalization| L