BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2760392 · Received September 26, 2012

    Report

    Report Number
    2531779-2012-11254
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP # 1 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. A 24 HOUR DURATION TEST WAS PERFORMED. NO UNPROGRAMMED BOLUSES OCCURRED DURING TESTING. A NORMAL 10 UNIT BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. BOLUS HISTORY VERIFIES A 8 UNIT BOLUS ON (B)(4) 2012 AT 3:44AM. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT AWOKE AT 6:30AM FEELING DIZZY AND SHAKY. THE PATIENT REPORTEDLY DRANK ICE TEA AND THEN CHECKED HER BLOOD GLUCOSE (BG) AND RECEIVED A BG READING OF 2MMOL/L. THE PATIENT REPORTEDLY THEN CONSUMED A GRANOLA BAR, AND HER BG ROSE TO 2.7MMOL/L. THE PATIENT REPORTEDLY WENT BACK TO SLEEP, AND HER BG UPON RE-AWAKENING WAS REPORTEDLY 7.0MMOL/L. AT THE TIME OF THE CALL TO ANIMAS CUSTOMER SUPPORT THE PATIENT'S BG WAS REPORTEDLY 11.3MMOL/L. THE REPORTER STATED THAT DURING A DOCTOR'S APPOINTMENT ON (B)(6) 2012, THE HCP NOTICED IN THE PUMP HISTORY AN 8.0 UNIT BOLUS DELIVERED AT 3:44AM. THE PATIENT REPORTEDLY DID NOT PROGRAM THIS BOLUS, AND THE REPORTER DENIED THAT THE BOLUS COULD HAVE BEEN PROGRAMMED MISTAKENLY. THE REPORTER DENIED ANY KEYPAD BUTTON ISSUES. THE REPORTER WAS ADVISED TO HAVE THE PATIENT DISCONNECT FROM THE PUMP AND GO ON A BACK-UP PLAN FOR INSULIN DELIVERY. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA AFTER RECEIVING A BOLUS THAT WAS NOT PROGRAMMED BY THE USER.

    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 14 YR Life Threatening| R