BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2895520 · Received January 3, 2013

    Report

    Report Number
    2531779-2013-00162
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 ALLEGING THE PATIENT'S BLOOD GLUCOSE (BG) WAS 44 MG/DL AT THE TIME OF THE CALL TO ANIMAS. THE PATIENT WAS CLAIMING TO BE HUNGRY AND THE REPORTER STATED THAT THE PATIENT HAD JUST CONSUMED A LOT OF CARBOHYDRATES. THE REPORTER STATED THAT SHE TOLD THE PATIENT TO WAIT A LITTLE WHILE BEFORE EATING MORE, AND THE PATIENT'S BG WENT LOW. THE REPORTER STATED THAT THE PATIENT RARELY HAS LOW BG, BUT HAD NOTICED THAT WHEN IT DOES OCCUR, IT IS AFTER A MEAL CONTAINING A LOT OF CARBOHYDRATES. THE REPORTER STATED THAT IF THE INSULIN PUMP RECOMMENDS MORE THAN JUST A COUPLE OF UNITS OF INSULIN AND THEY ADMINISTER WHAT THE WHAT PUMP RECOMMENDS, THE PATIENT'S BG GOES LOW. THE PUMP WAS REVIEWED WITH THE REPORTER AND THERE WAS NOTHING IN THE PUMP HISTORY SIGNIFICANT TO LOW BG. THE HISTORY DID SHOW MULTIPLE PRIMES AND FILL CANNULA RECORDS DUE TO REPORTED LOSS OF PRIME, BUT THE REPORTER STATED THE PATIENT WAS NOT CONNECTED TO THE PUMP WHEN THESE STEPS ARE PERFORMED. ALL THE PUMP SETTINGS WERE REVIEWED WITH THE REPORTER WHO CONFIRMED ALL THE SETTINGS WERE SET AS INTENDED FOR THE PATIENT. THE REPORTER STATED THAT SHE IS RELUCTANT TO CHANGE ANY OF THE PUMP SETTINGS. THE REPORTER WAS ADVISED TO CONTACT THE PATIENT¿S HEALTHCARE PROVIDER TO DISCUSS HER CONCERNS ABOUT BOLUSING FOR CARBOHYDRATES AT MEALTIME AND THE PATIENT'S LOW BG, HOWEVER, INFREQUENT THEY MIGHT BE, AS THE REPORTER STATED THAT SHE DOES NOT GIVE THE RECOMMENDED BOLUS AMOUNT IF THE PATIENT HAS EATEN A LOT OF CARBOHYDRATES BECAUSE SHE FEARS THE BG WILL GO TOO LOW. AT THE CONCLUSION OF THE CALL, THE PATIENT CONTINUED ON INSULIN PUMP THERAPY AND THE BG WAS BACK WITHIN TARGET RANGE WITH NO SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED LOW BG WHILE ON INSULIN PUMP THERAPY. IT WAS NOTED THAT THE PATIENT WAS NOT RECEIVING BOLUSES FOR CARBOHYDRATES CONSUMES PER PUMP RECOMMENDATIONS DUE TO THE FEAR OF THE BG GOING LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2257 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Life Threatening