BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2021636 · Received March 10, 2011

    Report

    Report Number
    2183996-2011-00475
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED HAVING HAD ADVERSE EFFECTS WHILE USING THE INFUSION SETS. PATIENT STATED HE BELIEVED THE NEEDLE WAS NOT LONG ENOUGH AND THAT HE HAD NOT RECEIVED ALL OF HIS INSULIN. PATIENT STATED HE FOUND A KINK IN HIS INFUSION SET AND THIS HAS CAUSED AN UNDER DELIVERY OF INSULIN. PATIENT REPORTED EXPERIENCING AN ELEVATED READING SO HE TOOK HIMSELF TO THE HOSPITAL ON (B)(6) 2011 AT 7:00 AM. PATIENT STATED THAT HE WAS ADMITTED TO THE HOSPITAL AT 11:30 AM WHERE THEY TESTED HIS BLOOD GLUCOSE LEVEL WITH A READING OF 47 MMOL/L (846 MG/DL). PATIENT REPORTED HE WAS PLACED ON AN UNKNOWN HOSPITAL PUMP AND GIVEN AN UNKNOWN FAST ACTING INSULIN. PATIENT STATED HE WAS MONITORED AND RELEASED WITH GOOD BLOOD GLUCOSE RESULTS AT 2:00 PM THE FOLLOWING DAY. NO FURTHER INFORMATION IS AVAILABLE. REQUESTED RETURN OF THE ALLEGED INFUSION SET FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| O| R (DATE OF TX (B)(6))| INSULIN INFUSION PUMP| INSULIN (DATE OF TX (B)(6))