BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3914051 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-18997
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 08/06/2014-PRODUCT ANALYSIS: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP¿S BLACK BOX AND HISTORY WERE REVIEWED. THE TOTAL DAILY DOSE HISTORY CORRECTLY REFLECTED THE PROGRAMMED BASAL RATES. THE PRIME HISTORY REVEALED SMALL PRIME VOLUMES DURING CARTRIDGE CHANGES. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, BOLUS DELIVERIES, AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. A DELIVERY ACCURACY TEST SHOWED THE PUMP¿S DELIVERY ACCURACY WAS WITHIN SPECIFICATION. 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) 2014, IT WAS REPORTED THE PATIENT¿S BLOOD GLUCOSE WAS ABOVE 600 MG/DL FROM (B)(6) 2014 TO (B)(6) 2014 WITH LEG MUSCLE WEAKNESS. IT WAS REPORTED THE PUMP SETTINGS HAD NOT BEEN CHANGED RECENTLY AND THE PATIENT SELF-TREATED WITH INSULIN DELIVERY THROUGH ANOTHER INSULIN PUMP. TROUBLESHOOTING COULD NOT BE COMPLETED. THIS COMPLAINT IS BEING REPORTED SINCE THE ALLEGED ADVERSE EVENT WAS ASSOCIATED WITH AN UNKNOWN ALLEGED INACCURATE DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391768 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening