BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2823348 · Received November 7, 2012

    Report

    Report Number
    2531779-2012-13259
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 12, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2012 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4)2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY SHOWED INCONSISTENCIES DUE TO THE TIME AND DATE ISSUE. THE DATES IN THE PUMP HISTORY CHANGE FROM (B)(6) 2012. EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS (ANM) ON BEHALF OF HER DAUGHTER (THE PATIENT) ALLEGING THAT THE PUMP DID NOT MAINTAIN THE TIME/DATE DURING THE PREVIOUS 2 BATTERY CHANGES. THE REPORTER CLAIMED THAT DUE TO THE ALLEGED ISSUE, THE PATIENT SUFFERED BLOOD GLUCOSE (BG) EXCURSIONS. DURING THE TIME OF CONCERN, THE PATIENT REPORTEDLY SUFFERED ELEVATED BG LEVELS BETWEEN "400-500 MG/DL" WITH A SYMPTOM OF NAUSEA. IN ONE INSTANCE, THE PATIENT BOLUSED A LARGE AMOUNT OF INSULIN TO CORRECT AND WOKE UP WITH A BG LEVEL OF "35 MG/DL" THE NEXT MORNING. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS AT THE TIME. SHE ADMINISTERED SELF CARE BY EATING A BOWL OF CEREAL TO BRING HER BG LEVEL UP. AT AN UNSPECIFIED POINT AFTER THE EVENT, THE PATIENT REPORTEDLY NOTICED THAT THE PUMP'S TIME OF DAY SETTING WAS INCORRECT. THE REPORTER MENTIONED THAT THE PATIENT USES DIFFERENT BASAL RATES THROUGHOUT THE DAY. SHE MENTIONED THAT THE DAY RATE IS HIGHER THAN THE NIGHT RATE. SHE ALSO NOTED THAT THE PATIENT'S BG LEVELS WERE GOING HIGH DURING THE DAYS FOR ABOUT A WEEK AFTER A BATTERY CHANGE WAS MADE. THE REPORTER WAS ADVISED TO CHECK THE PUMP'S DATE/TIME WITH BATTERY REMOVALS. THE PUMP WAS REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PATIENT SUFFERED HIGH AND LOW BG LEVELS THAT CAN BE ASSOCIATED WITH SERIOUS INJURIES. HOWEVER, THE PATIENT'S INJURIES CAN BE ATTRIBUTED TO POSSIBLE USE-ERROR CONSIDERING THE REPORTER ALLEGED THAT THE PUMP'S DATE AND TIME WERE NOT MAINTAINED AFTER A BATTERY CHANGE. THE PUMP DISPLAYS THE 'VERIFY' SCREEN AFTER IT IS REBOOTED AND THE TIME AND DATE MUST BE SET TO CONFIRM THE 'VERIFY' SCREEN. THE ISSUE IS NOT LIKELY TO CAUSE AN ADVERSE EVENT. IT IS UNKNOWN IF THE PATIENT CONFIRMED THE PUMP'S DATE/TIME AFTER THE BATTERY CHANGES WERE PERFORMED.

    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 13 YR Life Threatening