BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3834193 · Received May 27, 2014

    Report

    Report Number
    2531779-2014-14983
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 12/28/2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/09/2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX STARTS ON 2014-11-12. THE BLACK BOX DATA/HISTORIES FOR THE EVENT HAVE BEEN OVERWRITTEN DUE TO CONTINUED USE OF THE PUMP. AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. THE PUMP PASSED DELIVERY ACCURACY TESTING WITH NO DELIVERY DEFECTS FOUND. PUMP FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 REPORTING THAT THE PATIENT GAVE TWO BOLUSES TOTALING 5.55 UNITS FOR A CORRECTION OF A BLOOD GLUCOSE (BG) OF 10.9MMOL/L. THE PATIENT ENTERED BOLUS THROUGH NORMAL BOLUS AND THEY DID NOT USE EASY BG AS THEY WERE TRAINED. THE PATIENT STATED THAT THEY MANUALLY CALCULATED AND ENTERED THE TWO BOLUSES. PER THE ISF OF 1:2.5MMOL/L THEY SHOULD HAVE TAKEN 1.92 UNITS FOR CORRECTION. THIS WAS THE PATIENT¿S FIRST DAY ON THE PUMP. DURING THE CALL THE PATIENT¿S BG WENT DOWN TO 8.4MMOL/L WITHOUT SIGNS OR SYMPTOMS. THE PATIENT REFUSED EMERGENCY MEDICAL SERVICES (EMS). THE PATIENT SELF TREATED WITH HONEY. THE PATIENT WAS DISCONNECTED FROM THE PUMP AND ADVISED TO TALK TO HEALTHCARE PROFESSIONAL ON WHEN TO START PUMP THERAPY. MEDICAL SURVEILLANCE FOLLOWED UP WITH THE PATIENT ON (B)(6) 2014 AND THE PATIENT STATED THAT THEY DID GO TO THE HOSPITAL AND WAS ADMITTED FOR FOUR HOURS. THE PATIENT STATED THAT THEIR BG WAS 5.0MMOL/L AND THEY WERE BEING MONITORED BY THE HOSPITAL. THIS REPORT IS BEING MADE DUE TO THE HOSPITALIZATION EVENT THE PATIENT EXPERIENCED WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310269 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization