BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2090195 · Received May 6, 2011

    Report

    Report Number
    2183996-2011-01313
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    November 28, 2010
    Report Date
    April 13, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT HE REQUIRED MEDICAL INTERVENTION DUE TO AN ABSCESS CAUSED BY THE INFUSION SETS. PATIENT HAS BEEN ON INFUSION DEVICE THERAPY FOR 23 YEARS AND USED STEEL INFUSION NEEDLES WITHOUT ANY PROBLEMS. IN (B)(6) 2010, PATIENT RECEIVED STATIONARY TREATMENT DUE TO AN "OPEN SORE." HE SWITCHED TO A NEW TYPE OF INFUSION SET AT THAT TIME. PATIENT RECEIVED STATIONARY TREATMENT FROM (B)(6) 2010, FOR ANOTHER "OPEN SORE." WHILE IN THE HOSPITAL, HE USED ANOTHER TYPE OF INFUSION SET. THE INFUSION SET WAS INSERTED WITH THE INSERTION DEVICE. TWO DAYS LATER, PATIENT HAD A HARDENING ABSCESS, AND 2 MORE DAYS LATER, HE REQUIRED AN OPERATIVE OPENING OF THE ABSCESS (3 CM INCISION). ON (B)(6) 2011, PATIENT HAD ANOTHER HARDENED AREA DUE TO THE INFUSION SET. ON (B)(6) 2011, HE RECEIVED ANOTHER OPERATIVE OPENING AND HAD STATIONARY TREATMENT UNTIL (B)(6) 2011. AMBULANT MAINTENANCE ASSISTED WITH BANDAGING THE WOUND. PATIENT SWITCHED BACK TO A STEEL INFUSION NEEDLE. ALLEGED INFUSION SETS WERE NOT AVAILABLE TO RETURN FOR EVALUATION. ADDITIONAL DETAILS WERE NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R INSULIN (DATE OF TX: (B)(6))| INSULIN INFUSION DEVICE| (DATE OF TX: (B)(6))