BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3021626 · Received March 26, 2013

    Report

    Report Number
    2531779-2013-03091
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS STATING THAT ON (B)(6) 2013, THE PATIENT WAS TAKEN TO THE HOSPITAL FOR BLOOD GLUCOSE (BG) OF "HIGH" (>600MG/DL) WITH SYMPTOMS AND MODERATE KETONES. THE REPORTER DID NOT SPECIFY WHAT THE PATIENT'S SYMPTOMS WERE. THE PATIENT WAS REPORTEDLY GIVEN BOLUSES VIA THE PUMP AS WELL AS INSULIN INJECTIONS AND WAS TAKEN TO THE HOSPITAL WHEN HIS BG DID NOT RESPOND. THE REPORTER STATED THAT THE PATIENT REMAINED ON INSULIN PUMP THERAPY AT THE HOSPITAL AND WAS TREATED WITH INJECTIONS. THE REPORTER STATED THAT THE DOCTOR AT THE HOSPITAL WANTED THE PUMP REVIEWED WITH ANIMAS. TROUBLESHOOTING INDICATED ALL SETTINGS AND HISTORIES ARE CORRECT AND THE PUMP WAS FOUND TO BE DELIVERING AS PROGRAMMED. THE REPORTER ATTRIBUTED THE BG EXCURSION TO PUBERTY AND GROWTH SPURTS, STATING THAT THIS HAPPENS EACH TIME THE PATIENT HAS A GROWTH PERIOD. THE REPORTER STATED THEY HAD A FOLLOW-UP APPOINTMENT WITH THE PATIENT'S HEALTHCARE PROVIDER SCHEDULED FOR (B)(6) 2013. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA REQUIRING MEDICAL INTERVENTION WHILE ON INSULIN PUMP THERAPY AND IT IS UNCLEAR AT THIS TIME IF THE REPORTED BG EXCURSION CAN BE SOLELY ATTRIBUTED TO GROWTH SPURTS/PUBERTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124369 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| L| R