BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 311

    MDR report key: 3173512 · Received June 17, 2013

    Report

    Report Number
    1823260-2013-03652
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE FOR THE ISSUE. BASED UPON THE INFORMATION PROVIDED, AN ISSUE WITH THE SAMPLE PROBE WAS THE MOST LIKELY CAUSE OF THE EVENT AS NO FURTHER ISSUES WERE REPORTED AFTER THE SAMPLE PROBE WAS REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS ON TINA-QUANT HEMOGLOBIN A1C GEN.2 (HBA1C) FOR 18 PATIENT SAMPLES. IT WAS DETERMINED THAT OF THOSE 18 SAMPLES, 6 SAMPLES WERE ERRONEOUSLY REPORTED OUTSIDE THE LAB ON (B)(6) 2013 AND 4 SAMPLES WERE ERRONEOUSLY REPORTED OUTSIDE THE LAB ON (B)(6) 2013. THE CUSTOMER INDICATED THEY RUN THREE LEVELS OF QC ONCE A DAY, FIRST THING IN THE MORNING. THE CUSTOMER NOTED THAT ON (B)(6) 2013, QC WAS FINE, BUT ON (B)(6) 2013, QC WAS OUT HIGH FOR ALL LEVELS. THE CUSTOMER RECALIBRATED, WHICH BROUGHT QC BACK IN RANGE. PATIENT SAMPLES FROM (B)(6) 2013 WERE REPEATED AND AMENDED REPORTS WERE ISSUED. THE CUSTOMER ALSO INDICATED THAT THE SAME SITUATION HAPPENED ON (B)(6) 2013. ALL RESULTS ARE IN %. PATIENT 1 HAD AN INITIAL HBA1C RESULT OF 8.7 ON (B)(6) 2013. THE SAMPLE WAS REPEATED ON (B)(6) 2013 ON THE SAME ANALYZER AND GENERATED A REPEAT RESULT OF 6.7. PATIENT 2 HAD AN INITIAL HBA1C RESULT OF 10.4 ON (B)(6) 2013. THE SAMPLE WAS REPEATED ON (B)(6) 2013 ON THE SAME ANALYZER AND GENERATED A REPEAT RESULT OF 8.4. PATIENT 3 HAD AN INITIAL HBA1C RESULT OF 9.4 ON (B)(6) 2013. THE SAMPLE WAS REPEATED ON (B)(6) 2013 ON THE SAME ANALYZER AND GENERATED A REPEAT RESULT OF 7.4. PATIENT 4 HAD AN INITIAL HBA1C RESULT OF 9.6 ON (B)(6) 2013. THE SAMPLE WAS REPEATED ON (B)(6) 2013 ON THE SAME ANALYZER AND GENERATED A REPEAT RESULT OF 7.8. PATIENT 5 HAD AN INITIAL HBA1C RESULT OF 7.5 ON (B)(6) 2013. THE SAMPLE WAS REPEATED ON (B)(6) 2013 ON THE SAME ANALYZER AND GENERATED A REPEAT RESULT OF 5.9. PATIENT 6 HAD AN INITIAL HBA1C RESULT OF 8.8 ON (B)(6) 2013. THE SAMPLE WAS REPEATED ON (B)(6) 2013 ON THE SAME ANALYZER AND GENERATED A REPEAT RESULT OF 6.6. PATIENT 7 HAD AN INITIAL HBA1C RESULT OF 11.4 ON (B)(6) 2013. THE SAMPLE WAS REPEATED ON (B)(6) 2013 ON THE SAME ANALYZER AND GENERATED A REPEAT RESULT OF 8.7. PATIENT 8 HAD AN INITIAL HBA1C RESULT OF 13.8 ON (B)(6) 2013. THE SAMPLE WAS REPEATED ON (B)(6) 2013 ON THE SAME ANALYZER AND GENERATED A REPEAT RESULT OF 10.3. PATIENT 9 HAD AN INITIAL HBA1C RESULT OF 7.7 ON (B)(6) 2013. THE SAMPLE WAS REPEATED ON (B)(6) 2013 ON THE SAME ANALYZER AND GENERATED A REPEAT RESULT OF 5.9. PATIENT 10 HAD AN INITIAL HBA1C RESULT OF 9.9 ON (B)(6) 2013. THE SAMPLE WAS REPEATED ON (B)(6) 2013 ON THE SAME ANALYZER AND GENERATED A REPEAT RESULT OF 8.0. THE INITIAL RESULTS FOR ALL 10 PATIENTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DEEMED THE REPEAT RESULTS TO BE THE CORRECT RESULTS AND ISSUED AMENDED REPORTS. THE CUSTOMER DID NOT HAVE ANY KNOWLEDGE OF ANY PATIENTS BEING TREATED BASED ON THE ERRONEOUS RESULTS. THE LOT OF HBA1C REAGENT IN USE WAS 66926901, WITH AN EXPIRATION DATE OF 11/30/2013. THE LOT OF HBA1C HEMOLYZING REAGENT IN USE WAS (B)(4), WITH AN EXPIRATION DATE OF 04/30/2014. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE FOR THE ISSUE. HE CHECKED THE FLUIDICS SYSTEM, PHOTOMETER AND RINSE MECHANISM LEVELS. HE REPLACED THE SAMPLE PROBE AS PART OF TROUBLESHOOTING. THE CUSTOMER PERFORMED QC AND ACCEPTED ALL THE RESULTS. A PRECISION CHECK WAS ALSO RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272920 COBAS 311 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1