BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4231934 · Received November 6, 2014

    Report

    Report Number
    2531779-2014-31732
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/18/2014 WITH THE FOLLOWING FINDINGS: THE ORIGINAL COMPLAINT COULD NOT BE DUPLICATED. ON (B)(6) 2014 AT 19:32, THE BLACK BOX REVEALED A 1.05 UNIT BOLUS OF A PROGRAMMED 2.05 BOLUS WAS DELIVERED DUE TO A EAW 176; THE PARTIAL DELIVERY WAS ABORTED BY THE USER. THE REMAINING 1.0 UNIT WAS DELIVERING AT 19:34. ON (B)(6) 2014 AT 20:14 A 0.65 UNIT BOLUS WAS PROGRAMMED AND 0.00 UNITS WERE DELIVERED DUE TO EAW 175; PARTIAL DELIVERY AND THE USER ABORTED THE PUMP WARNING. FOLLOWING THE WARNING, THE 0.65 UNIT WAS THEN SUCCESSFULLY DELIVERED. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ERRORS, ALARMS OR WARNINGS EMITTED. THE TOTAL DAILY DOSES CORRECTLY ADDED UP AND THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. 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) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE (BG) VALUES RANGING FROM 37 MG/DL TO 469 MG/DL WITH LARGE KETONES, EXTREME DROWSINESS/DIFFICULTY WAKING UP/CONFUSION, AND ABDOMINAL PAIN/VOMITING ASSOCIATED WITH AN INACCURATE DELIVERY ISSUE. REPORTEDLY, THE PATIENT RESUMED PUMP THERAPY AND WAS TREATED IN THE EMERGENCY ROOM BY THEIR HEALTHCARE PROVIDER. IT WAS REPORTED THAT THE PATIENT RECEIVED INSULIN VIA THEIR PUMP AND VIA INJECTION FOR TREATMENT. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS REVEALED THAT THE TOTAL DAILY DOSE FOR THE BASAL DELIVERY WAS RECORDED AS PROGRAMMED AND WAS CORRECTLY DELIVERING; HOWEVER, THE BOLUS TOTALS IN THE HISTORY DID NOT CORRECTLY ADD UP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED A SERIOUS BG EXCURSION DUE TO AN INACCURATE DELIVERY ISSUE WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715567 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Life Threatening| R