BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2062660 · Received April 11, 2011

    Report

    Report Number
    2531779-2011-02433
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 12, 2011
    Report Date
    March 12, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    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 DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT HIS BLOOD GLUCOSE ELEVATED TO 300 MG/DL WITH SYMPTOMS OF VOMITING AND LARGE KETONES. HIS BEDTIME BLOOD GLUCOSE READ 129 MG/DL THE NIGHT PRIOR TO THE REPORTED HYPERGLYCEMIC READING. THE PT TOOK A CORRECTION BOLUS INSULIN DOSE VIA THE PUMP AND SYRINGE. THE PT'S BLOOD GLUCOSE WAS LOWERED TO 250 MG/DL WITH NO HYPERGLYCEMIC SYMPTOMS. DURING TROUBLESHOOTING, THE ANIMAS HEALTHCARE REP CONCLUDED THAT THE PUMP IS WORKING ACCORDINGLY AND THAT THE CAUSATION OF THE HIGH BLOOD GLUCOSE MAY BE DUE TO THE USER ERROR AND/OR INSULIN DISPENSE SITE ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT REPORTEDLY DEVELOPED HYPERGLYCEMIA WHILE HIS DIABETES WAS MANAGED WITH THE ANIMAS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS 2020

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening| R