BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3011527 · Received March 19, 2013

    Report

    Report Number
    2531779-2013-02771
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT HAS HAD ELEVATED BLOOD GLUCOSE (BG) LEVELS SINCE (B)(6) 2013, BETWEEN 400-500MG/DL. MOM HAS BEEN CORRECTING HIGH BG WITH MANUAL INJECTIONS; PATIENT HAS NOT SOUGHT MEDICAL CARE. THE SITE/SET/CART HAS BEEN CHANGED SEVERAL TIMES AND ISSUE STILL PERSISTS. BG AT TIME OF CALL IS 448MG/DL AND PATIENT FEELING TIRED AND IRRITABLE. MOM STATES PRIOR TO CALLING CUSTOMER TECHNICAL SUPPORT (CTS) SHE GAVE A CORRECTION BOLUS VIA MANUAL INJECTION. MOM STATES BASAL RATES ARE CORRECT. CTS REVIEWED TIME/DATE AND DISCOVERED THAT TIME AND DATE WAS INCORRECT ON PUMP. INSTEAD OF 4:03 PM TIME DISPLAYED IS 4:03AM AND DATE WAS (B)(6) 2013. CTS INSTRUCTED MOM IN CORRECTING TIME/DATE. MOM IS NOT SURE HOW LONG TIME/DATE WAS INCORRECT AND IS NOT SURE IF TIME IS MAINTAINED AFTER DOING A BATTERY CHANGE. TIME MAY HAVE BEEN PUT INTO PUMP INCORRECTLY BECAUSE MOM WAS NOT SURE HOW TO CHANGE TIME FROM AM TO PM. CTS REVIEWED THE REST OF PUMP HISTORY AND FOUND NO ALARMS OR DATA THAT WOULD INDICATE A HALT IN INSULIN DELIVERY. INSTRUCTED MOM THAT INCORRECT TIME IN PUMP SEEMS TO HAVE RESULTED IN THE BG EXCURSIONS, ESPECIALLY DUE TO THE FACT THAT THE PATIENT HAS MULTIPLE BASAL RATES. INSTRUCTED MOM TO CONTINUE TO MONITOR TIME ON PUMP AND MONITOR BG, TO CALL CTS BACK IF THE CORRECT TIME ON THE PUMP DOES NOT RESOLVE THE PATIENT'S BG EXCURSIONS. MOM DENIES ANY CHANGES IN PATIENT ACTIVITY, OR ANY ILLNESSES. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT A PATIENT ON PUMP THERAPY EXPERIENCED HYPERGLYCEMIA RELATED TO THE TIME IN THE PUMP BEING OFF BY 12 HOURS FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113901 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening