BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1870038 · Received October 15, 2010

    Report

    Report Number
    1823260-2010-05818
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 213 MG/DL AND 77 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER STATED SHE WAS FEELING HYPOGLYCEMIC SYMPTOMS WITH THE READINGS AND SHE SELF-TREATED WITH APPLE JUICE. REPORTER ALSO ALLEGED OBTAINING THE RESULTS OF 77 MG/DL AND 143 MG/DL ON THE SAME AVIVA SYSTEM BACK TO BACK WITHIN 10 MINUTES. REPORTER STATED THAT SHE WAS FEELING HYPOGLYCEMIC WITH THE 77 MG/DL RESULT AND SHE SELF- TREATED BEFORE OBTAINING THE 143 MG/DL RESULT. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO DISCREPANT GLUCOSE (GLUCM) RESULTS GENERATED BY UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER HAS BEEN NOTICING PATIENT RESULTS DO NOT MATCH AND QC IMPRECISION SINCE (B)(4) 2010. WHEN THE DUPLICATE RESULTS DO NOT MATCH, SAMPLE IS RUN ON ANOTHER INSTRUMENT FOR CONFIRMATION. NO SPECIFIC PATIENT RESULTS OR NUMBER PATIENT SAMPLES INVOLVED WERE PROVIDED. THERE WAS NO EFFECT TO THE PATIENTS OR TO THE USER.

    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 NA 302646

    Patients

    Seq Age Sex Outcome Treatment
    1 083 YR