BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1885233 · Received October 28, 2010

    Report

    Report Number
    1823260-2010-06410
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 25, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    A CAREGIVER (CG) CONTACTED (B)(4) REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING DRAIN. THE CARE GIVER (CG) STATED THAT THE HOME PATIENT (HP) DISCONNECTED TO USE THE BATHROOM. THE DRAIN CYCLE STARTED AND THE HC ALARMED. (B)(4) EXPLAINED SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP AND ADVISED THE CG TO RESTART THERAPY WITH NEW SUPPLIES. THE CG CONFIRMED TO START WITH NEW SUPPLIES AND CALL BACK WITH ANY QUESTIONS. ON (B)(6) 2010 (B)(4) SPOKE WITH THE HOME PATIENT (HP) WHO COULD NOT RECALL IF SHE RECONNECTED TO THE SETUP AFTER INTENTIONALLY DISCONNECTING. THE HP STATED HER THERAPY WAS RESUMING WITHOUT COMPLICATIONS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER DETAIL WAS AVAILABLE.

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED THE RESULTS OF 349 MG/DL AND 167 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 302870

    Patients

    Seq Age Sex Outcome Treatment
    1 087 YR NOVOLOG (SLIDING SCALE)| LANTUS (DAILY)