BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1841707 · Received September 22, 2010

    Report

    Report Number
    1823260-2010-05627
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 19, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    REPORTER ALLEGED OBTAINING THE RESULTS OF 191 MG/DL, 148 MG/DL, 137 MG/DL, 117 MG/DL, 310 MG/DL AND 125 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER STATED THAT HER HUSBAND GAVE HER SOME ORANGE JUICE BECAUSE SHE WAS FEELING HYPOGLYCEMIC SYMPTOMS. NO 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

    THE USER FAILED OUT HIGH ON ONE EXTERNAL PROFICIENCY SURVEY SAMPLE FOR LIPASE ON THE COBAS C501 ANALYZER. THE INITIAL SURVEY RESULT FOR LIPASE GAVE 135 U/L. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY. THE ACCEPTABLE SURVEY RANGE FOR LIPASE WAS 22 U/L TO 43 U/L. ON (B)(6) 2010 THE USER REPEATED THE SAME SURVEY SAMPLE WHICH YIELDED A LIPASE RESULT OF 32 U/L. THERE WERE NO PATIENT SAMPLES REPORTED TO BE INVOLVED WITH THE EVENT. THE LIPASE REAGENT LOT NUMBER WAS 62440001. THE FIELD SERVICE REPRESENTATIVE DID NOT FIND A CAUSE FOR THE EVENT. HE RAN PERFORMANCE TESTS WHICH WERE WITHIN SPECIFICATION.

    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 302589

    Patients

    Seq Age Sex Outcome Treatment
    1 038 YR