BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® RAPID-D INFUSION SET

    MDR report key: 3831948 · Received May 27, 2014

    Report

    Report Number
    1823260-2014-03700
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    June 17, 2011
    Report Date
    May 27, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    PATIENT REPORTED DEVELOPING SORES WHEN USING A DIFFERENT TYPE OF HEAD SET IN THE PAST WHEN SHE FIRST RECEIVED THE PUMP ON (B)(6) 2011. PATIENT STATED SHE DEVELOPED SORES AND THEY TURNED INTO AN INFECTION THAT SHE HAD TO HAVE AN ANTIBIOTIC PRESCRIBED FOR. PATIENT HAS DISCARDED THE ALLEGED INFUSION SET. PATIENT REPORTED SHE CHANGED TO A DIFFERENT TYPE OF INFUSION SET AND THE ISSUE STOPPED OCCURRING. NO PRODUCT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311712 ACCU-CHEK ® RAPID-D INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 059 YR Required Intervention HUMALOG| CYMBALTA| LEVEMIR| VITAMIN D3| ASPIRIN PAB 81 MG| PRAVASTATIN| NITROGLYCERIN| MAGNESIUM| PRILOSEC| ESTERASE| POTASSIUM| TRAMADOL