BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3091860 · Received May 3, 2013

    Report

    Report Number
    2531779-2013-05835
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/30/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWS DATA STARTING ON (B)(6) 2013. THE DATA FROM THE TIME OF THE COMPLAINT IS UNAVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. THERE WERE NO ALARMS RELATED TO THE COMPLAINT OBSERVED IN THE CURRENT PUMP HISTORY; ONLY TYPICAL USAGE WAS OBSERVED. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, CUSTOMER TECHNICAL SUPPORT (CTS) CONTACTED THE PATIENT TO FOLLOW-UP WITH A PREVIOUSLY REPORTED ISSUE, AND DURING THE CALL THE PATIENT MENTIONED THAT FROM (B)(6) 2012 TO (B)(6) 2013, SHE EXPERIENCED LOW BLOOD GLUCOSE (BG) BETWEEN 40MG/DL AND 50MG/DL WITH OCCASIONAL SWEATING. THE PATIENT REPORTEDLY SELF-TREATED WITH JUICE, AND WAS WORKING WITH HER HEALTHCARE PROVIDER ON BASAL SETTINGS ADJUSTMENTS. THE PATIENT WAS REPORTEDLY USING U500 INSULIN IN THE PUMP FROM (B)(6) 2012. USE OF THIS TYPE OF INSULIN IN THE PUMP IS NOT AN APPROVED USE OF THE PUMP. THE PATIENT STATED THAT AT THE TIME OF THE CALL WITH CTS SHE WAS BACK TO USING NOVOLOG U100 IN THE PUMP. THE PATIENT DECLINED TO TROUBLESHOOT THE PUMP, STATING THAT THERE WAS NO PUMP MALFUNCTION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPOGLYCEMIA WHILE USING INSULIN PUMP THERAPY WITH MISUSE AS A CAUSE OR CONTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193575 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening