BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242934 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11743
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. USER ERROR IS CONTRIBUTORY, AS THE CANNULA FILL STEP WAS DONE TWICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/16/2013 WITH THE FOLLOWING FINDINGS: TESTING CONFIRMED USE ERROR AS THE CAUSE OF THE EVENT. BEFORE PRIMING THE PUMP DISPLAYS THE APPROPRIATE WARNING: ¿BE SURE SET IS DISCONNECTED FROM YOUR BODY. THEN SELECT CONTINUE¿. PUMP PASSED 29 HOUR FLOW ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A CLINICAL DIABETES EDUCATOR AND PUMP TRAINER, CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: PATIENT¿S CAREGIVER FOUND HIM UNRESPONSIVE AT 9A.M. ON (B)(4) 2013. CAREGIVER CALLED PARAMEDICS, AND THE PATIENT WAS TAKEN TO HOSPITAL . HIS BLOOD GLUCOSE (BG) WAS 20 MG/DL. PATIENT REMAINED IN HOSPITAL, SHE BELIEVES FOR 4 DAYS AND WAS DISCHARGED HOME. THE PATIENT'S HOME HEALTH NURSE HAD DONE HIS SET/CARTRIDGE/SITE CHANGE ON (B)(6) 2013 AT 948PM WHEN SHE HAD COMPLETED THE PRIME AND FILL CANNULA OF 1 UNIT. SHE THEN REPORTS THAT THE PUMP SIGNALED LOW BATTERY SO SHE HAD TO RE-PRIME THE PUMP AGAIN ABOUT 10 MINUTES LATER. SHE AGAIN DID A FILL CANNULA OF 1 UNIT. PATIENT WAS ATTACHED FOR BOTH FILL CANNULA AMOUNT AND RECEIVED AN EXTRA 1.3 UNITS. THE PRIMES HE WAS UNATTACHED FOR. PATIENT PERFORMS BOLUSING WITH THE PUMP AND SET INSERTION BUT IS ASSISTED FOR PUMP FUNCTIONS. THE HOME HEALTH NURSE CHANGES THE INFUSION SET FOR THE PATIENT TWICE A WEEK, BUT HAD NOT BEEN FORMALLY TRAINED BY A PUMP TRAINER. THE REPORTER HAS SINCE INSTRUCTED HER ABOUT THE FILL CANNULA AND ONLY COMPLETING THIS STEP WITH A NEW SITE, ONE TIME. PATIENT HAD RECEIVED EXTRA INSULIN VIA BOTH FILL CANNULAS. THE REPORTER HAS ALSO INSTRUCTED THE HOME HEALTH NURSE THAT SHE MUST GO TO HIS HOME EARLIER IN DAY, NOT AT NIGHT FOR SET CHANGES. THERE IS NO ALLEGATION OF PUMP MALFUNCTION. THIS COMPLAINT IS BEING REPORTED BECAUSE A PATIENT ON PUMP THERAPY EXPERIENCED HYPOGLYCEMIA RELATED TO USE ERROR OF FILLING CANNULA TWICE AND WITH WRONG AMOUNT OF INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343939 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Hospitalization