BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2972646 · Received February 21, 2013

    Report

    Report Number
    2531779-2013-02005
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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. THE REASON FOR THE ADVERSE EVENT HAS BEEN ATTRIBUTED TO USE ERROR (INADEQUATE RESPONSE TO AN ALARM).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE DATA FROM THE TIME OF THE REPORTED EVENT WAS UNAVAILABLE FOR REVIEW AS IT WAS OVERWRITTEN DUE TO CONTINUED PUMP USE. A REVIEW OF THE AVAILABLE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. A REWIND, LOAD, AND PRIME SEQUENCE WAS SUCCESSFULLY PERFORMED WITH NO ALARMS OCCURRING. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES AND NO LOSS OF PRIME ALARMS OCCURRING. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. A LOSS OF PRIME WAS INDUCED AND THE PUMP EMITTED THE APPROPRIATE AUDIO-VISUAL ALERT.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP EMITTED MULTIPLE LOSS OF PRIME ALARMS. THE REPORTER STATED THAT THE PUMP LOST PRIME IN THE MIDDLE OF THE NIGHT AND THE PATIENT WAS NOT AWARE OF NO INSULIN DELIVERY. THE PATIENT WOKE-UP WITH A BLOOD GLUCOSE (BG) OF 505 MG/DL WITHOUT SYMPTOMS. THE PATIENT WAS TREATED FOR HIGH BG VIA PUMP AND SENT TO SCHOOL. THE PUMP WAS NOT AVAILABLE FOR TROUBLESHOOTING AT THE TIME OF THE CALL. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT THAT RESULTED FROM AN INADEQUATE RESPONSE TO A PUMP ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75659 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening