BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 8593677 · Received May 8, 2019

    Report

    Report Number
    2531779-2019-03063
    Event Type
    Injury
    Date Received
    May 8, 2019
    Report Date
    May 6, 2019
    Manufacturer
    ANIMAS LLC
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PATIENT EXPERIENCED ON (B)(6) 2019, A BLOOD GLUCOSE OF 700MG/DL, WITH ABDOMINAL PAIN, NAUSEA, AND VOMITING, ASSOCIATED WITH AN ALLEGED CALL SERVICE ALARM ISSUE. REPORTEDLY, THE PATIENT DISCONTINUED PUMP THERAPY, AND WAS TREATED IN THE HOSPITAL WITH INSULIN VIA INJECTION, ANTIBIOTICS, AND OTHER TREATMENT. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS REVEALED A CALL SERVICE 070/064 ALARM OCCURRED DURING THE REWIND STEP. THE PUMP TUBING WAS REPORTEDLY BEING USED BEYOND THE TWO TO THREE DAYS AS INDICATED IN THE INSTRUCTIONS FOR USE. THE PATIENT HAD AN INSERTION SITE INFECTION, AND AN UNRELATED CASE OF PNEUMONIA. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH USE ERROR OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387049 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R