BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2792695 · Received October 16, 2012

    Report

    Report Number
    2531779-2012-12337
    Event Type
    Injury
    Date Received
    October 16, 2012
    Report Date
    September 19, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 07/15/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/08/2014 WITH THE FOLLOWING FINDINGS: THE LAST BASAL DELIVERY WAS ON 09/22/2012, TOTAL DAILY DOSE (TDD) ADDS UP AND EQUALS THE PROGRAMMED BASAL TARGET. THE DISPLAY IS DIM AND PINKISH UPON START UP. THE PUMP REFLECTED 24U AFTER A 24HR ON 1U/HR BASAL DURATION TEST. THE PRODUCT DELIVERS WITHIN SPECIFICATIONS. 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 PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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. (SERIAL #): (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS TO REPORT A HIGH BLOOD GLUCOSE (BG) EXCURSION. THE PATIENT REPORTED OBTAINING BGS OVER 500MG/DL FOR PAST 2 WEEKS. AT TIME OF CALL, THE PATIENT STATED HIS CURRENT BG WAS 446 MG/DL. THERE WAS NO MENTION OF SYMPTOMS. THE PATIENT INFORMED CUSTOMER SUPPORT THAT HE WAS TAKING 10U OF REGULAR INSULIN FOR BGS OVER 500MG/DL. AT THE TIME OF TROUBLESHOOTING, THE PATIENT CONFIRMED THE PUMP WAS SET TO THE CORRECT DATE AND TIME. THE PATIENT INFORMED CUSTOMER SUPPORT THAT HE DID NOT USE THE PUMP'S ADVANCED FEATURES. THE PATIENT DENIED ANY ALARMS OR ISSUES WITH THE PUMP. AT THE TIME OF THE CALL, THE PATIENT STATED HE TOOK 2 STEROID SHOTS EARLIER THAT DAY FOR HIS ARTHRITIS IN HIS ELBOWS. CUSTOMER SUPPORT ADVISED THE PATIENT TO CONTACT HIS HCP FOR POSSIBLE CHANGES IN INSULIN SETTINGS. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT OBTAINED UNEXPLAINED HIGH BG READING OVER 500 MG/DL WHILE ON INSULIN PUMP THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening