BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1941907 · Received December 23, 2010

    Report

    Report Number
    2531779-2010-03089
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 26, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE LAY USER/PT'S MOTHER CONTACTED ANIMAS ALLEGING THAT THE PT'S INSULIN PUMP WAS CALCULATING INCORRECT BOLUS DOSES. ON AN UNSPECIFIED DATE, WHILE THE PT WAS AT SCHOOL, THE REPORTER CLAIMED THAT THE SUBJECT PUMP RECOMMENDED A 9 UNIT BOLUS FOR AN INTAKE OF 20 GRAMS OF CARBOHYDRATE. IT IS NOT KNOWN WHAT THE PT'S BLOOD GLUCOSE LEVEL WAS AT THE TIME OF THE RECOMMENDATION. THE PT'S MOTHER REPORTED THAT THE SCHOOL NURSE SUSPECTED THAT THE BOLUS CALCULATION WAS INCORRECT AND ADVISED THE PT TO REMAIN WITH HER. IT IS NOT KNOWN IF THE PT DEVELOPED SYMPTOMS; HOWEVER, THE PT'S MOTHER REPORTED THAT THE PT'S BLOOD GLUCOSE DROPPED TO "42 MG/DL" AFTER THE BOLUS AND THE NURSE TREATED THE PT WITH JUICE. AT AN UNSPECIFIED TIME ON (B)(6), 2010, THE PT'S MOTHER ALSO REPORTED THAT THE PT'S BLOOD GLUCOSE DROPPED TO "36 MG/DL" AND SHE TREATED HIM WITH JUICE. THE REPORTER STATED THAT THE PT HAD DEVELOPED NUMBNESS IN HIS LEGS, A SYMPTOM HE ASSOCIATES WITH HYPOGLYCEMIA. THE PT'S MOTHER ALSO INFORMED THE ANIMAS CDE INVOLVED WITH THIS CONTACT THAT THE SUBJECT PUMP'S CASE CRACKED DURING A FALL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Life Threatening| R