BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK INFUSION SET

    MDR report key: 2861022 · Received December 3, 2012

    Report

    Report Number
    2183996-2012-01859
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 15, 2011
    Report Date
    November 15, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE PATIENT REPORTED SHE HAD AN ALLERGIC REACTION AND LOST CONSCIOUSNESS AND WAS TAKEN OFF OF THE INFUSION DEVICE, CALL WAS DISCONNECTED. UPON FOLLOW WITH THE PATIENT ON (B)(6) 2012 SHE REPORTED THAT 'A WHILE AGO' SHE WAS HOSPITALIZED DUE TO AN ALLERGIC REACTION SHE DID NOT RECALL HOW LONG SHE WAS HOSPITALIZED. SHE STATED THAT SHE HAS HAD 2 STROKES AND 2 HEART ATTACKS AND DOES NOT HAVE A GOOD MEMORY. SHE STATED THAT SHE WAS TAKEN BACK TO THE HOSPITAL A COUPLE OF DAYS AFTER BEING RELEASED. SHE REPORTED BEING IN A COMA DURING ONE OF THE HOSPITALIZATIONS. SHE STATED THAT HER PHYSICIAN ADVISED HER SHE WAS ALLERGIC TO THE INFUSION DEVICE. SHE DOES NOT RECALL WHAT TYPE OF INFUSION SET WAS IN USE AT THE TIME OF THE EVENT. SHE STATED THAT SHE HAS BEEN OFF OF INFUSION THERAPY FOR APPROXIMATELY ONE YEAR. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R INSULIN INFUSION PUMP| INSULIN| AND RELATED ACCESSORIES