BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1852484 · Received October 4, 2010

    Report

    Report Number
    1823260-2010-05870
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 17, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE COMPACT PLUS SYSTEM. REFERENCE MEDWATCH REPORT WITH (B)(6) FOR THE AVIVA SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 339 MG/DL (COMPACT PLUS) AND 150 MG/DL (AVIVA) NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED THROUGH BAXTER'S AFTERHOURS CALL SERVICE FROM A HOME PATIENT (HP) WITH A REPORT OF A SYSTEM ERROR 2240 (AIR IN SET) ALARM ON THE HOMECHOICE (HC) DURING THERAPY. THE HP HAD ALREADY DISCONNECTED FROM THE HC MACHINE. THE HP REPORTED THE HEATER LINE CONNECTION WAS LOOSE. THE PATIENT WAS ADVISED TO START THE THERAPY AGAIN WITH NEW SUPPLIES OR TO PERFORM A MANUAL EXCHANGE. THE HP WILL END THERAPY SINCE THEY WERE ALREADY IN DWELL 6 OF 6. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20722042

    Patients

    Seq Age Sex Outcome Treatment
    1 083 YR SYNTHROID| METFORMIN| ZOCOR| CLONIDINE| POTASSIUM| FUROSEMIDE| ASPIRIN| CALCIUM PLUS D| DIAZEPAM| AEROSOL INHALER| CENTRUM SILVER| ANTACAND