BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINA-QUANT HEMOGLOBIN A1C GEN.2

    MDR report key: 2121096 · Received June 13, 2011

    Report

    Report Number
    1823260-2011-03193
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 18, 2011
    Report Date
    August 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LCP
    PMA / PMN Number
    K072714
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CLARIFICATION OF RESPONSE: IT IS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE COULD NOT BE DETERMINED AS ADDITIONAL INFORMATION WAS NOT PROVIDED FOR FURTHER INVESTIGATION. FALSELY HIGH HEMOGLOBIN A1C RESULTS MAY LEAD TO UNNECESSARY MEDICAL INTERVENTION SUCH AS A CONFIRMATORY TEST FOR DIABETES AND PREDIABETES AND AN UNNECESSARY ADJUSTMENT OF MEDICATION AND DIET IN DIABETICS. MAJOR CHANGES IN MEDICATION (INSULIN DOSAGE) WOULD BE MONITORED BY REGULAR BLOOD GLUCOSE TESTING, NOT BY A HEMOGLOBIN A1C TEST. IN THIS CASE THE CUSTOMER STATED THAT THE TREATMENT WAS DELAYED. THE DOCTOR RECOGNIZED DISCORDANCE BETWEEN THE RESULTS. NO FURTHER INFORMATION REGARDING THE TREATMENT GIVEN TO THE PATIENT WAS PROVIDED. THE PATIENT WAS NOT HARMED AND THE PATIENT'S CURRENT CONDITION WAS STATED TO BE "HEALTHY".

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE HEMOGLOBIN A1C RESULTS FOR ONE PATIENT SAMPLE WHEN TESTED ON A COBAS INTEGRA 800 ANALYZER, (B)(4). THE PATIENT SAMPLE WAS COLLECTED AND RECEIVED ON (B)(6) 2011, TESTING WAS PERFORMED ON (B)(6) 2011. THE INITIAL HEMOGLOBIN RESULT WAS 0.1050 (10.50%). THE RESULT OF 0.105 WAS REPORTED OUTSIDE THE LABORATORY AND THE DOCTOR QUESTIONED THE RESULT. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY AND WAS RETESTED ON A TOSOH ANALYZER AND RECOVERED 0.050 (5.0%). THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY IN A CORRECTED REPORT ON (B)(6) 2011. THE SAME SAMPLE WAS REPEATED (B)(6) 2011 ON THE COBAS INTEGRA 800 ANALYZER AND RECOVERED 5.22%. THE PATIENT TREATMENT WAS DELAYED. THE PATIENT WAS NOT HARMED. THE PATIENT'S CURRENT CONDITION IS "HEALTHY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TINA-QUANT HEMOGLOBIN A1C GEN.2 ASSAY, GLYCOSYLATED HEMOGLOBIN LCP ROCHE DIAGNOSTICS NA 638841

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR