BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2801984 · Received October 23, 2012

    Report

    Report Number
    2531779-2012-12663
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    October 2, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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'S MOTHER CONTACTED ANIMAS AND REPORTED THAT THE PATIENT HAD EXPERIENCED MULTIPLE MORNING LOW BLOOD GLUCOSE (BG) VALUES AND AS RECENTLY AS (B)(6) 2012 HAD EXPERIENCED A SEVERE LOW BG (POSSIBLY IN THE SINGLE DIGITS). THE REPORTER DID NOT PROVIDE SPECIFIC LOW BG OBTAINED ON (B)(6) 2012, BUT CLAIMED THE PATIENT WAS SYMPTOMATIC INCLUDING "UNINTELLIGIBLE SPEECH". THE PATIENT WAS TREATED WITH APPLE JUICE AND THE REPORTER STATED THAT RAISED THE PATIENT'S BG TO 25 MG/DL. PRIOR TO THE LOW BG, THE PATIENT ADMITTING HAVING A HIGH BG THE NIGHT BEFORE (READING NOT PROVIDED) AND ADMINISTERED A CORRECTION BOLUS. THE REPORTER INFORMED CUSTOMER SUPPORT THAT SHE DID DISCUSS LOW BGS WITH PATIENT'S HCP AND ADJUSTMENTS TO THE PATIENT'S BASAL DELIVERY WERE MADE, BUT THE REPORTER STATED THE PATIENT WAS STILL HAVING EARLY MORNING LOWS IN THE 30'S AND 40'S MG/DL RANGE. AT THE TIME OF THE CALL, THE PATIENT'S MOTHER REPORTED THAT THE PATIENT HAD BEEN OFF OF THE ANIMAS PUMP FOR APPROXIMATELY 1 WEEK AND ON AN ONMIPOD PUMP. THE REPORTER DECLINED TO REVIEW THE PUMP AND INFORMED ANIMAS CUSTOMER SUPPORT THAT IF THE PATIENT DECIDED TO RESUME THE ANIMAS PUMP SHE WOULD CALL BACK. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA WHILE ON INSULIN PUMP THERAPY. BASED ON THE INFORMATION PROVIDED, IT IS NOT KNOWN IF THE ANIMAS DEVICE CAUSED AND/OR CONTRIBUTED TO THE LOW BG DUE TO A PRODUCT MALFUNCTION, USE ERROR OR MISUSE.

    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 15 YR Life Threatening| R