BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242830 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11732
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/07/2014 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP HISTORY WAS REVIEWED AND SHOWED THE INFORMATION FROM THE REPORTED DATE OF (B)(6) 2013 HAD BEEN OVERWRITTEN. THE LAST BASAL DELIVERY WAS ON RECORDED ON (B)(6) 2014; NO ACTIVITY OUTSIDE OF NORMAL USE WAS OBSERVED. THE TOTAL DAILY DOSE ADDED UP CORRECTLY AND REFLECTED THE USER¿S PROGRAMMED BASAL TARGET. THE PUMP POWERED ON PROPERLY AND DISPLAYED THE VERIFY SCREEN. DURING TESTING, THE EZ-PRIME SEQUENCE WAS PERFORMED SUCCESSFULLY AND THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO DELIVERY INTERRUPTION OCCURRING. DURING TESTING THE PUMP WAS FOUND TO BE DELIVERING ACCURATELY. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY WAS DISCOLORED. THE ISSUE WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION. 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, THE REPORTER CONTACTED ANIMAS STATING THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE IN THE RANGE OF 30MG/DL TO 300MG/DL. THE SYMPTOMS WERE REPORTEDLY UNCLEAR. THE PATIENT REPORTEDLY HAD KETONES. IT WAS NOTED DURING A REVIEW OF THE PUMP HISTORY, THE TOTAL DAILY DOSE WAS PRIMARILY COMPOSED OF BASAL INSULIN DELIVERY AND NOT BOLUS DELIVERY; 32 UNITS OUT OF THE 37 UNITS OF INSULIN THAT THE PATIENT RECEIVED FOR 7 DAYS WAS BASAL. THE PATIENT REPORTEDLY ONLY PERFORMED PARTIAL BOLUSES BECAUSE SHE HAD EXPERIENCED LOW BGS IN THE AFTERNOON. THE PATIENT CLAIMED SHE WAS UNSURE WHY SHE WAS HAVING ISSUES WITH LOW BGS BUT BELIEVED IT WAS DUE TO STRESS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A BG EXCURSION WHILE ON INSULIN PUMP THERAPY. USE ERROR CONTRIBUTED TO THE REPORTED EVENT BECAUSE THE PATIENT WAS NOT MONITORING HER BGS FREQUENTLY, IT WAS UNCLEAR WHY THE PATIENT WAS HAVING ISSUES WITH LOW BGS, THE PATIENT WAS ONLY ADMINISTERING PARTIAL CORRECTION BOLUSES FOR HER CARBOHYDRATE INTAKE, THE PATIENT WAS NOT CHANGING THE INFUSION SITE/SET AT THE RECOMMENDED TIME AND WAS CHANGING THE SITE/SET 3 DAYS OR MORE, HAD ACCIDENTALLY USED LANTUS IN THE PUMP INSTEAD OF APIDRA AND MAY HAVE OTHER HEATH ISSUES UNRELATED TO THE DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343471 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening