BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3790106 · Received May 5, 2014

    Report

    Report Number
    1823260-2014-03180
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 27, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT REPORTED THAT THE DOWN BUTTON ON HER INFUSION DEVICE HAD ONLY BEEN FUNCTIONING INTERMITTENTLY, BUT TWO WEEKS AGO THE BUTTON COMPLETELY STOPPED FUNCTIONING. THE PATIENT ALSO REPORTED THAT THE RUBBER COVERING OF THE BUTTON WAS COMPLETELY WORN OFF. NO ADVERSE EVENT WAS REPORTED. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266969 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR DEXILANT DR 60 MG ONCE A DAY| FUROSEMIDE 40MG 1 PILL PER DAY| ASPIRIN 325 MG ONCE A DAY| CRESTOR 20 MG ONCE PER DAY| EXFORGE 10-320MG 1 PILL PER DAY| HUMALOG U100 AOBUT 116 UNITS PER DAY IN PUMP