BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3021491 · Received March 26, 2013

    Report

    Report Number
    2531779-2013-03082
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/20/2013 WITH THE FOLLOWING FINDINGS: THE BLACK BOX BEGINS ON (B)(6) 2013. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA AND HISTORIES FOR THE EVENT ON (B)(6) 2013 HAVE BEEN OVERWRITTEN. A REVIEW OF THE ACCESSIBLE BLACK BOX AND ALARM HISTORY SHOWS NO ERRORS OR ALARMS ASSOCIATED WITH THE COMPLAINT. THE TOTAL DAILY INSULIN DELIVERIES ADD UP CORRECTLY AND REFLECT THE USER'S PROGRAMMED BASAL RATES. THE PUMP COMPLETED AND PASSED A 29 HOUR FLOW ACCURACY TEST; AND IT WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATION. A CRACK NEAR THE CASE SEAL OF THE BATTERY COMPARTMENT WAS OBSERVED. UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN.

    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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PATIENT WAS HOSPITALIZED FOR BLOOD GLUCOSE LEVELS IN THE 26 TO 28 MMOL/L RANGE WITH MODERATE KETONES AND VOMITING. THE REPORTER INDICATED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS WERE WITHIN NORMAL RANGE SINCE BEING RELEASED FROM THE HOSPITAL. THE PUMP WAS REVIEWED WITH THE REPORTER WHO CONFIRMED THAT THERE WERE NO ASSOCIATED ALARMS IN THE HISTORY, THE BOLUS HISTORY AND DELIVERIES WERE CORRECT, THE BASAL SETTINGS AND TOTAL DAILY DOSE ADDED CORRECTLY AND THE PRIME HISTORY APPEARED CORRECT. THE REPORTER WAS ADVISED THAT THE PUMP APPEARED TO BE DELIVERING AS PROGRAMMED. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED FOR HYPERGLYCEMIA OF UNCLEAR CAUSE WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124532 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| L