BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 7145273 · Received December 24, 2017

    Report

    Report Number
    2531779-2017-29269
    Event Type
    Injury
    Date Received
    December 24, 2017
    Date of Event
    November 29, 2017
    Report Date
    November 29, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    UDI-DI
    10840406100976
    PMA / PMN Number
    P130007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510 (K) #: K080639

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON THE SAME DATE, THE PATIENT INITIATED A 911/EMERGENCY PROTOCOL AND WAS HOSPITALIZED FOR KETOACIDOSIS (DKA) ASSOCIATED WITH AN ALLEGED PUMP MALFUNCTION. THE TYPE OF PUMP MALFUNCTION WAS NOT SPECIFIED. REPORTEDLY, THE PATIENT WAS TREATED BY A HEALTHCARE PROVIDER BUT INFORMATION ABOUT THE TYPE OF TREATMENT RECEIVED COULD NOT BE OBTAINED. IT COULD NOT BE DETERMINED WHETHER OR NOT THE PATIENT CONTINUED PUMP THERAPY. TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS) COULD NOT BE COMPLETED THEREFORE THE UNSPECIFIED PUMP ISSUE COULD NOT BE CONFIRMED. ANIMAS HAS MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW UP, HOWEVER, THE REPORTER DID NOT RESPOND. NO FURTHER INFORMATION WAS AVAILABLE; IF FURTHER INFORMATION IS PROVIDED A FOLLOW UP REPORT WILL BE SUBMITTED. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED AND THE PUMP COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924271 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION 10840406100976

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| L