BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4717880 · Received April 22, 2015

    Report

    Report Number
    2531779-2015-13504
    Event Type
    Injury
    Date Received
    April 22, 2015
    Report Date
    April 13, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/19/2015 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. THE BLACK BOX SHOWS UNEXPLAINED POWER ON RESET ON (B)(6) 2015 18:45; DELIVERIES RESUMED AT 19:12. ON (B)(6) 2015 19:31 AN UNEXPLAINED POR OCCURRED; DELIVERIES RESUMED AT 20:28. AN UNEXPLAINED POR OCCURRED ON (B)(6) 2015 18:32; WHEN PUMP WAS POWERED BACK ON THE TIME/DATE WERE SET INCORRECTLY TO (B)(6) 2015 07:40. A MANUAL TIME CHANGE WAS THEN MADE FROM (B)(6) 2015 20:27 TO (B)(6) 2015 08:30. THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT USER'S PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. NO ALARMS OCCURED DURING 24HR DURATION TESTING. UNABLE TO DUPLICATE THE COMPLAINT.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PUMP HAD AN INACCURATE DELIVERY ISSUE STARTING ON (B)(6) 2015, AND THE PATIENT ALLEGEDLY HAD A BLOOD GLUCOSE (BG) IN THE 20 MG/DL RANGE WITH SHAKINESS, UNSTEADINESS, CONFUSION, SEVERE DIZZINESS, AND IMPAIRED COGNITION. THE PATIENT RECEIVED NO UNUSUAL TREATMENT FOR THE EXCURSION, AND HAS DISCONTINUED PUMP USE. THE REPORTER WAS UNWILLING/UNABLE TO COMPLETE TROUBLESHOOTING WITH CUSTOMER SUPPORT, BUT CONFIRMED TIME/DATE WERE SET CORRECTLY AND THAT THE PATIENT HAD NO CONCURRENT MEDICAL ISSUES THAT WOULD HAVE CONTRIBUTED TO THE EXCURSION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED TO HYPOGLYCEMIA AND THE PUMP COULD NOT BE RULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268400 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening