BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2852573 · Received November 30, 2012

    Report

    Report Number
    2531779-2012-14102
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 05/01/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX BEGAN ON (B)(4) 2015. DUE TO CONTINUOUS USE OF THE PUMP, THE BLACK BOX DATA AND HISTORIES FOR THE EVENT HAVE BEEN OVERWRITTEN. THE AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USERS PROGRAMMED BASAL RATES. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. 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) 2012, THE REPORTER CONTACTED ANIMAS STATING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE IN THE RANGE OF 42 MG/DL TO 55 MG/DL WITH DIZZINESS. THE PATIENT REPORTEDLY FAINTED AND WAS HOSPITALIZED. IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED HIGH BGS FOR TWO NIGHTS AND THEN REPORTED ON THE AFTERNOON OF (B)(6) 2012, THE PATIENT STARTED TO EXPERIENCE THE LOW BGS. THE PATIENT REPORTEDLY HAD GROWN AN INCH IN THE LAST MONTH. THERE WERE REPORTEDLY NO CHANGES IN MEDICATIONS, DIET OR ACTIVITIES. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP WITH THE REPORTER AND THERE WERE NO PROGRAMMING/SETTINGS ISSUES NOTED ON THE PUMP. THERE WERE NO SITE/SET OR CARTRIDGE ISSUES NOTED. THERE WAS REPORTEDLY ONE "LOW CARTRIDGE" ALARM EMITTED BY THE PUMP NOTED IN THE PUMP ALARM HISTORY. IT WAS NOTED THAT THE PATIENT HAD THE BASAL RATES ADJUSTED ON THE PUMP LATER ON DURING THE DAY BY THE HEALTH CARE PROVIDER (HCP) AND THE PATIENT WAS DOING FINE. THE PUMP IS NOT BEING RETURNED AND THE PATIENT IS CURRENTLY ON THE PUMP. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. IT IS NOT CLEAR AS TO WHETHER OR NOT THE PUMP CONTRIBUTED TO THE REPORTED BG EXCURSION.

    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 11 YR Hospitalization| L| R