BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3944541 · Received July 18, 2014

    Report

    Report Number
    2531779-2014-20685
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/07/2014 WITH THE FOLLOWING FINDINGS: THE PUMP HISTORY SHOWS THAT THE PUMP WAS MANUALLY SUSPENDED ON (B)(6) 2014 18:09 AND MANUALLY RESUMED AT 19:09. THERE WERE NO ALARMS RELATED TO THE COMPLAINT NOTED IN THE ALARM HISTORY. THE BASAL AND BOLUSES ADD UP APPROPRIATELY TO TOTAL THE TOTAL DAILY DOSE AND SHOWING THE PUMP WAS DELIVERING ACCURATELY UNTIL THE LAST DATE USED. THE PUMP PASSED A DELIVERY ACCURACY TEST. NO EAW¿S OCCURRED DURING TESTING. INVESTIGATORS WERE UNABLE TO DUPLICATE REPORTED COMPLAINT. THE DISPLAY SCREEN HAS A PINKISH CONTRAST. THE BATTERY COMPARTMENT IS CRACKED BETWEEN BUMPER PAD AND COVER. RETURNED BATTERY CAP AND RETURNED CARTRIDGE CAP USED TO COMPLETE TESTING. 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.

    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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 REPORTING THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 560MG/DL WITH STRONG FRUITY BREATH, RAPID DEEP BREATHING/SHORTNESS OF BREATH/CHEST PAIN, ABDOMINAL PAIN/VOMITING, EXTREME DROWSINESS/DIFFICULTY WAKING/CONFUSION, POLYDIPSIA, POLYURIA AND NAUSEA. THE PATIENT WAS HOSPITALIZED WITH DIABETIC KETOACIDOSIS. THE PATIENT WAS TREATED WITH INSULIN VIA THE PUMP, INSULIN VIA INJECTION, AND INSERTION SITE CHANGE. THE REPORTER STATED THAT THE PATIENT¿S HEALTHCARE PROFESSIONAL WANTED TO THE PUMP REPLACED. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION THE PATIENT EXPERIENCED DUE TO AN ALLEGED HISTORY SETTINGS (INACCURATE DELIVERY) ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423203 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization