BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2980055 · Received February 27, 2013

    Report

    Report Number
    2531779-2013-02195
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 2, 2013
    Report Date
    February 4, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    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. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 8/17/15. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/29/2015 WITH THE FOLLOWING FINDINGS: UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. THE BLACK BOX BEGINS ON (B)(6) 2015. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA AND HISTORIES FOR THE EVENT HAVE BEEN OVERWRITTEN. AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. BATTERY CAP WAS NOT RETURNED. TEST BATTERY CAP AND RETURNED CARTRIDGE CAP USED FOR TESTING. 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, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: THE PATIENT'S BLOOD GLUCOSE (BG) DROPPED TO 40MG/DL ON SATURDAY MORNING. THE PATIENT NEARLY PASSED OUT, FELL AND HIT HEAD ON TILED FLOORING. HE HAS BUMP ON HEAD BUT DID NOT BLEED. MOM APPLIED ICE REDUCING BUMP. MOM TREATED LOW BG WITH PRUNE JUICE AND HONEY AND BG RESPONDED APPROPRIATELY. DURING THE COURSE OF THE CALL, THE MOM ALSO REPORTED ELEVATED BGS OCCURRING AROUND 11PM, AS HIGH AS 400MG/DL. MOM STATES, PATIENT HAD HIGH BG OF 400MG/DL LAST NIGHT AND MOM CHANGED SITE AND GAVE CORRECTION BOLUS AND BG RETURNED TO NORMAL LEVELS. HCP RECENTLY INCREASED BASAL RATE IN PUMP TO ADJUST FOR HIGHS AND NOW PATIENT HAD SOME LOWS WITH LAST SATURDAY BEING THE WORST. MOM WANTED TO REVIEW PUMP SETTINGS WITH CUSTOMER TECHNICAL SUPPORT (CTS), AND WANTED TO KNOW HOW TO CHECK ADVANCED SETTINGS IN PUMP, I.E. I:C, ISF, TARGETS AND IOB, BUT THE PATIENT AND PUMP ARE NOT CURRENTLY WITH MOM. DAD LATER RETURNED CALL TO CTS. CTS FOUND NO PRODUCT DEFECT AND ADVISED DAD TO CONTACT THE HEALTH CARE PROVIDER (HCP) REGARDING , AND REVIEW SETTINGS FOR ALL THE RATES AND TO DISCUSS HIGH AND LOW BGS AND SETTINGS, EXPLAINED THAT WE CAN PROGRAM THE PUMP DIFFERENTLY BUT HE NEEDS TO SPEAK TO HCP FIRST AND DETERMINE THE PROPER SETTINGS. THERE IS NO INDICATION OF PUMP MALFUNCTION. THE ELEVATED BG DOES NOT MEET THE CRITERIA OF AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT A PATIENT ON PUMP THERAPY EXPERIENCED HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83733 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Life Threatening