BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3092678 · Received May 3, 2013

    Report

    Report Number
    2531779-2013-05873
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ALLEGATION OF A PUMP MALFUNCTION OR DEFECT. THEREFORE, THE PUMP WAS NOT REQUESTED FOR EXAMINATION AND THE PATIENT CONTINUES TO USE THE PUMP. USE ERROR WAS DETERMINED TO BE THE SOLE CAUSE OF THE REPORTED HYPOGLYCEMIA. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE PATIENT CONTACTED ANIMAS TO REPORT THAT THE PUMP ALARMED WITH A MESSAGE ABOUT LOSS OF PRIME. AT THE TIME OF THE CALL, CUSTOMER TECHNICAL SUPPORT (CTS) ASSESSED THE PATIENT'S CONDITION TO BE CONFUSED AND ASKED THE PATIENT TO OBTAIN ASSISTANCE FROM FAMILY MEMBER. IT WAS DISCOVERED THAT A FAMILY MEMBER WAS IN THE PROCESS OF TREATING THE PATIENT WITH ORAL CARBOHYDRATES DUE TO BLOOD GLUCOSE (BG) READING OF 51 MG/DL. REPORTEDLY, THE PUMP WAS DISCONNECTED DURING THE CALL WHICH ENDED AROUND 2:30 AM. THE PATIENT REPORTED THAT THE PREVIOUS BG WAS 262 MG/DL AT 6:06 PM. THE PATIENT'S BG WAS 185 MG/DL AT THE END OF THE CALL. THE FOLLOWING SEQUENCE OF EVENTS WAS REPORTED. THE PATIENT WAS IN THE PROCESS OF CHANGING HER CARTRIDGE. SHE PLACED THE CARTRIDGE IN THE PUMP BUT DID NOT PERFORM THE REWIND STEP. PAPERS ON THE COUNTERTOP WERE DESCRIBED AS WET. THE PATIENT INSISTED THAT SHE WAS DISCONNECTED DURING THE CARTRIDGE REPLACEMENT PROCESS. ONCE THE PATIENT'S BG WAS SAID TO BE 81 MG/DL, CTS COMPLETED TROUBLE SHOOTING OF THE PUMP. THE PRIME HISTORY SHOWED A PRIME OF 142 UNITS OF INSULIN AT 11:34 PM. THE INSULIN SENSITIVITY FACTOR WAS FOUND TO BE PROGRAMMED INCORRECTLY; THE PATIENT REPORTED THE VALUE SHOULD BE SET AT 65 AND THE PUMP VALUE IS PROGRAMMED 15. THE PATIENT CONFIRMED THAT SHE MADE AN ERROR IN PROGRAMMING. FINALLY A REVIEW OF THE BOLUS HISTORY INDICATED THAT THE PATIENT DELIVERED TWO BOLUSES DURING THE EVENING. THE FAMILY MEMBER REPORTED THAT THE PATIENT LIKED TO KEEP BG ON THE LOW SIDE, THAT SHE EATS LITTLE AND BOLUSES TOO MUCH AT TIMES. THE PATIENT ADMITTED THAT SHE OVERRIDES THE PUMP CALCULATIONS AND DELIVERS A SELF CALCULATED BOLUS. THIS COMPLAINT IS BEING REPORTED BECAUSE SEVERAL USE ERRORS CONTRIBUTED TO A HYPOGLYCEMIC EVENT THAT REQUIRED ASSISTANCE FROM ANOTHER PERSON FOR TREATMENT. THERE IS NO ALLEGATION OR EVIDENCE THAT THE REPORTED PUMP ALARM CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193657 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening