BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2832177 · Received November 14, 2012

    Report

    Report Number
    2531779-2012-13601
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 20, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS TO REPORT THE I:C RATIO ON HIS PUMP WAS INCORRECT. AT THE TIME OF THE CALL, THE PATIENT MENTIONED TO CUSTOMER SUPPORT THAT HE HAD AN UNEXPLAINED LOW BLOOD GLUCOSE (BG) EXCURSION ON (B)(6) 2012. THE PATIENT REPORTED THAT AT 5:30AM THAT MORNING HE WOKE UP AND HIS BG WAS "IN THE TEENS." THE PATIENT INFORMED CUSTOMER SUPPORT THAT HE WAS CONFUSED AND HE COULD NOT GET UP AND WALK AND HAD TO CRAWL TO THE TABLE TO GET A COKE. AT THE TIME OF TROUBLESHOOTING, CUSTOMER SUPPORT NOTED THAT REVIEW OF PUMP HISTORY DID NOT REVEAL ANYTHING SIGNIFICANT WITH THE PUMP THAT WOULD HAVE CAUSED AND/OR CONTRIBUTED TO THE LOW BG. CUSTOMER SUPPORT NOTED THERE WERE NO ASSOCIATED ALARMS OR NO ABNORMAL OR UNEXPLAINED BOLUSES OR PRIMES. THE PATIENT DENIED ANY CHANGES IN HIS DIET OR ROUTINE ACTIVITY OR ILLNESS PRIOR TO THE LOW BG. HOWEVER, AT THE TIME OF THE CALL, THE PATIENT MENTIONED THAT HE DID NOT FEEL THAT THE PUMP WAS RECOMMENDING ENOUGH INSULIN DURING HIS LUNCH TIME WHEN ENTERING IN CARBS AND AS A RESULT HE WAS MANUALLY CALCULATING BOLUS AMOUNT. AT THE TIME OF THE CALL, THE PATIENT REVIEWED I:C RATIOS ON HIS OLD AND NEW PUMP. IT WAS NOTED THAT IN THE OLD PUMP THE I:C AT 12A WAS 1U-4G AND IN THE NEW PUMP IT WAS SET TO 1U-25G. THE PATIENT CHANGED THE SETTING IN THE NEW PUMP TO REFLECT SETTING IN OLD PUMP AND MENTIONED HE MAY HAVE "MESSED UP THE SETTING" IN THE PUMP DURING PROGRAMMING. THE PATIENT WAS ADVISED TO DISCUSS RATES IN THE PUMP WITH HCP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA WHILE ON INSULIN PUMP THERAPY. . INSULIN PUMP USE COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE LOW BG EVENT.

    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 47 YR Life Threatening| R