BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3952578 · Received July 23, 2014

    Report

    Report Number
    2531779-2014-21087
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED TO BE 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

    FOLLOW-UP #1: DATE OF SUBMISSION 6/23/2016. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/07/2016 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. THE BB STARTS ON (B)(6) 2016. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA/HISTORIES FOR THE EVENT HAVE BEEN OVERWRITTEN. TDD¿S WERE FOUND TO CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. A DELIVERY ACCURACY WAS SUCCESSFULLY COMPLETED. PUMP FOUND TO BE DELIVERING ACCURATELY AND WITHIN REQUIRED RANGE. 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, THE REPORTER CONTACTED ANIMAS ALLEGING THAT ON (B)(6) 2014, THE PATIENT HAD EXPERIENCED A BLOOD GLUCOSE (BG) OF 522 MG/DL WITH ABDOMINAL PAIN AND VOMITING AND AN UNSPECIFIED LEVEL OF KETONES. AT THE TIME OF THE CALL, THE BG WAS 388 MG/DL AND THE VOMITING HAD STOPPED. REPORTEDLY, THE PATIENT REMAINED ON THE PUMP AND DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS REVEALED THAT THE BASAL DELIVERY TOTALS IN THE TOTAL DAILY DOSE DID MATCH THE ACTIVE BASAL PROGRAM, THE BASAL HISTORY MATCHED THE ACTIVE BASAL PROGRAM SETTINGS, AND THE BOLUS TOTALS MATCHED AND WERE ALL RECORDED AS PROGRAMMED. THE PATIENT WAS ABLE TO DELIVER ONE UNIT VIA AIR BOLUS WHILE ON THE PHONE WITH CTS AND IT DID RECORD CORRECTLY IN THE PUMP¿S HISTORY. IT WAS REPORTED THAT THE PATIENT HAD A DECREASE IN HYDRATION LEVEL AND THERE WERE RECENT CHANGES MADE TO THE BASAL RATE BY THEIR HEALTHCARE PROVIDER. IT WAS DETERMINED BY CTS THAT THE CHANGE IN THE PATIENT¿S HYDRATION LEVEL AND AN ISSUE WITH THE STORAGE OR QUALITY OF INSULIN CONTRIBUTED TO THE INCREASE IN THE BG. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH AN UNSPECIFIED INSULIN QUALITY OR STORAGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431548 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening