BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5709659 · Received June 9, 2016

    Report

    Report Number
    2531779-2016-11461
    Event Type
    Injury
    Date Received
    June 9, 2016
    Report Date
    May 25, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 06/27/20160 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/15/2016 WITH THE FOLLOWING FINDINGS: THE BB SHOWS A MANUAL TIME/DATE CHANGE FROM (B)(6) 2016 19:11 TO (B)(6) 2016 19:10. PUMP HISTORY SHOWS THE PUMP WAS MANUALLY SUSPENDED AND RESUMED ON (B)(6) 2016. THE PUMP WAS EXERCISED FOR 24HRS WITH A 2.0U/HR BASAL RATE; AT END TESTING THE BASAL HISTORY CORRECTLY SHOWED 2.0U AND TDD SHOWED 48.0U. THE TDD¿S ADD UP CORRECTLY AND REFLECT USER'S PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. NO DELIVERY INTERRUPTIONS OR EAW¿S OCCURRED DURING TESTING. UNABLE TO DUPLICATE THE COMPLAINT. DISPLAY SCREEN HAS A PINKISH CONTRAST. BATTERY COMPARTMENT IS CRACKED ABOVE THE BUMPER PAD. 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. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY SETTINGS ISSUE. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 502MG/DL WITH EXTREME DROWSINESS, POLYDIPSIA, NAUSEA, VOMITING, SHORTNESS OF BREATH, SYMPTOMS OF DEHYDRATION, CONFUSION AND LARGE KETONES. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM. THEY WERE TREATED WITH INSULIN VIA PUMP AND IV FLUIDS. CUSTOMER SUPPORT (CS) AND THE BASAL HISTORY DOES NOT MATCH ACTIVE BASAL PROGRAM. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION THE PATIENT EXPERIENCED DUE TO AN ALLEGED HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365129 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization