BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3211111 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09839
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/18/2013 WITH THE FOLLOWING FINDINGS: THE TOTAL DAILY DOSE ADDS UP CORRECTLY. A 10U NORMAL BOLUS AND A 10U AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. NO HYPERSENSITIVE KEYS WERE OBSERVED ON KEYPAD. THE PUMP WAS EXERCISED ON A 24-HR DURATION TEST WITH A 1.0U/HR BASAL RATE; AT THE END OF THE DURATION TEST THE TOTAL DAILY DOSE SHOWED 24.0U; THE PUMP WAS CORRECTLY CALCULATING THE DAILY INSULIN TOTAL. THE PUMP WAS TESTED ON A 29 HOUR FLOW TEST; THE PUMP PASSED THE REQUIRED TEST AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFICATION. INVESTIGATORS WERE UNABLE TO DUPLICATE THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. THE REPORTER STATED THAT THE PATIENT WAS NOT GETTING INSULIN AND HER BLOOD GLUCOSE (BG) HAS BEEN IN THE 300MG/DL RANGE AND NO SYMPTOMS. THE SITE/SET REPORTEDLY WAS CHANGED MULTIPLE TIMES AND THE ISSUE WAS NOT RESOLVED. IT WAS NOTED THAT THE CARTRIDGE DISPLAYED 170 UNITS OF INSULIN AFTER IT WAS FILLED. DURING A REVIEW OF THE PUMP HISTORY, THE BASAL RATE REPORTEDLY WAS FOUND TO BE CORRECT. THE TOTAL DAILY DOSE (TDD) REPORTEDLY WAS FOUND TO BE INACCURATE; 0-863 UNITS REPORTEDLY WAS INDICATED IN PUMP HISTORY INSTEAD OF 10.863 UNITS OF INSULIN. THE REPORTER DENIED HAVING ISSUES WITH THE DISPLAY SCREEN. IT WAS NOTED THAT THE PUMP WAS RECEIVED ABOUT A MONTH AGO. THE HEALTH CARE PROVIDER (HCP) REPORTEDLY ADVISED THE REPORTER THAT THE PATIENT DISCONNECT FROM THE PUMP, TO GO ON A BACK-PLAN AND REQUESTED THE PUMP BE REPLACED. THE PATIENT REPORTEDLY WAS USING INSULIN INJECTIONS IN ORDER TO MAINTAIN BG LEVELS. THE REPORTED BG DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309912 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR