BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5855077 · Received August 8, 2016

    Report

    Report Number
    2531779-2016-19486
    Event Type
    Injury
    Date Received
    August 8, 2016
    Report Date
    July 16, 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. 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 9/8/2016. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/16/2016 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED W/THE FOLLOWING BASAL PROGRAM SETTINGS: 0.825U/HR AT 00:00, 0.925U/HR AT 6:30, 0.85U/HR AT 17:00 AND 0.8750U/HR AT 19:00 WITH A TOTAL OF 21.149U/DAY. A REVIEW OF THE PUMP BASAL CHANGE HISTORY ON THE DATE OF THE COMPLAINT, (B)(4) 2016 DOES NOT MATCH BASAL PROGRAM 1. THE BASAL PROGRAM CHANGING TO 0.825 U/HR AT 17:00, 0.850 U/HR AT 19:00 AND 0.800U/HR AT 23:00 WHEN PROGRAM 1 INDICATES BASAL DELIVERY SHOULD BE 0.850U/HR, 0.875U/HR AND 0.875U/HR AT THOSE TIMES RESPECTIVELY. THE PUMP WAS PUT ON A BASAL PROGRAM OF 1U/HR FOR 24 HOURS DURING THE INVESTIGATION; PUMP HISTORY INDICATES THE TDD WAS RECORDED ACCURATELY. UNRELATED TO THE COMPLAINT THE DISPLAY IS DIM/FADING (PINK) AND THERE ARE TWO BATTERY COMPARTMENT CRACKS BELOW THE BUMPER.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PATIENT HAD A BLOOD GLUCOSE OF 509 MG/DL WITH DRY MOUTH. THE PATIENT RECEIVED NO UNUSUAL TREATMENT. DURING TROUBLESHOOTING, CUSTOMER SUPPORT FOUND THAT THE BASAL DELIVERY TOTALS IN TDD DO NOT MATCH ACTIVE BASAL PROGRAM, AND THERE WAS NO KNOWN CAUSE FOR THE DISCREPANCY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE DISCREPANCY WAS NOT RESOLVED AND THE PATIENT EXPERIENCED HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505948 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening