BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPA

    MDR report key: 1511232 · Received October 14, 2009

    Report

    Report Number
    1823260-2009-07124
    Event Type
    Malfunction
    Date Received
    October 14, 2009
    Date of Event
    September 20, 2009
    Report Date
    October 14, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED IN SUPPLEMENTAL MEDWATCH REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE MPA PIPETTED THE WRONG SAMPLE INTO THE INCORRECT CUPS. CUSTOMER STATES HE HAD THREE SPECIMENS THAT GAVE WRONG RESULTS COMPARED TO THE ORIGINAL TUBE. THE MPA PIPETTED THE SAMPLES AND THEY WERE SENT TO THE INSTRUMENT AND RUN, THE RESULTS DID NOT MATCH RESULTS FROM THE ORIGINAL TUBES. (THE TECH NOTICED THE RESULTS WERE HIGH. HE RAN THE SAMPLES FROM THE ORIGINAL TUBES AND GOT DIFFERENT RESULTS). HE CORRECTED THE RESULTS AND CALLED THE ER DOCTOR WITH THE RIGHT RESULTS, HE SAID THEY HAVE NO WAY OF KNOWING IF THE PATIENTS WERE TREATED. THE FOLLOWING RESULTS WERE PROVIDED, CUSTOMER WAS UNSURE WHICH COBAS ANALYZER SOME OF THESE REPEATS WERE TESTED ON. THREE DIFFERENT TYPES OF SAMPLE CONTAINERS ALL FROM SAME SAMPLE: SAMPLE CONTAINER 1 (MPA CUP, COBAS 2) INITIAL RESULTS, BUN 201 MG PER DL (ACCOMPANIED BY HIGH DATA FLAG); CALCIUM 14.7 MG PER DL (ACCOMPANIED BY HIGH DATA FLAG); CO2 15.6 MMOL PER L (ACCOMPANIED BY LOW DATA FLAG); CREATININE 18.1 MG PER DL (ACCOMPANIED BY HIGH DATA FLAG); SODIUM 191 MMOL PER L (ACCOMPANIED BY HIGH DATA FLAG); POTASSIUM 8.94 MMOL PER L (ACCOMPANIED BY HIGH DATA FLAG). SAMPLE CONTAINER 2 (ORIGINAL TUBE, UNKNOWN COBAS) INITIAL RESULTS, BUN 10 MG PER DL; CALCIUM 9.3 MG PER DL: CO2 24.1 MMOL PER L; CREATINE 1.0 MG PER DL; SODIUM 134 MMOL PER L (ACCOMPANIED BY LOW DATA FLAG); POTASSIUM 5.4 MMOL PER L (ACCOMPANIED BY HIGH DATA FLAG). SAMPLE CONTAINER 1 (ORIGINAL MPA CUP, COBAS 1) REPEAT RESULTS, BUN RESULT 220 MG PER DL (ACCOMPANIED BY HIGH DATA FLAG); CALCIUM 12.4 MG PER DL (ACCOMPANIED BY HIGH DATA FLAG), CO2 10.6 MMOL PER L (ACCOMPANIED BY LOW DATA FLAG), CREATININE 18.6 MG PER DL (ACCOMPANIED BY HIGH DATA FLAG), SODIUM 193 MMOL PER L (ACCOMPANIED BY HIGH DATA FLAG), POTASSIUM 8.9 MMOL PER L (ACCOMPANIED BY HIGH DATA FLAG). SAMPLE CONTAINER 1 (ORIGINAL MPA CUP, COBAS 2) REPEAT RESULTS, BUN 219 MG PER DL (ACCOMPANIED BY HIGH DATA FLAG), CREATININE 20.1 MG PER DL (ACCOMPANIED BY HIGH DATA FLAG). SAMPLE CONTAINER 3 (ORIGINAL TUBE PUT IN NEW CUP, UNKNOWN COBAS) INITIAL RESULTS, BUN 11 MG PER DL, CREATININE 1.0 MG PER DL.

    Additional Manufacturer Narrative · 2

    ADDITIONAL INFORMATION WILL BE PROVIDED IN SUPPLEMENTAL MEDWATCH REPORT.

    Description of Event or Problem · 2

    CUSTOMER REPORTED THE MPA PIPETTED THE WRONG SAMPLE INTO THE INCORRECT CUPS. CUSTOMER STATES HE HAD THREE SPECIMENS THAT GAVE WRONG RESULTS COMPARED TO THE ORIGINAL TUBE. THE MPA PIPETTED THE SAMPLES AND THEY WERE SENT TO THE INSTRUMENT AND RUN, THE RESULTS DID NOT MATCH RESULTS FROM THE ORIGINAL TUBES. (THE TECH NOTICED THE RESULTS WERE HIGH. HE RAN THE SAMPLES FROM THE ORIGINAL TUBES AND GOT DIFFERENT RESULTS). HE CORRECTED THE RESULTS AND CALLED THE ER DOCTOR WITH THE RIGHT RESULTS, HE SAID THEY HAVE NO WAY OF KNOWING IF THE PATIENTS WERE TREATED. THE FOLLOWING RESULTS WERE PROVIDED, CUSTOMER WAS UNSURE WHICH COBAS ANALYZER SOME OF THESE REPEATS WERE TESTED ON. TWO DIFFERENT TYPES OF SAMPLE CONTAINERS ALL FROM SAME SAMPLE: SAMPLE CONTAINER 1 (MPA CUP, UNKNOWN COBAS), BUN 91 MG PER DL (ACCOMPANIED BY HIGH DATA FLAG), CREATININE 13.6 MG PER DL (ACCOMPANIED BY HIGH DATA FLAG), POTASSIUM 8.6 MMOL PER L (ACCOMPANIED BY HIGH DATA FLAG). SAMPLE CONTAINER 2 (ORIGINAL TUBE, UNKNOWN COBAS), BUN 9 MG PER DL, CREATININE 0.6 MG PER DL (ACCOMPANIED BY LOW DATA FLAG), POTASSIUM 3.2 MMOL PER L (ACCOMPANIED BY LOW DATA FLAG).

    Additional Manufacturer Narrative · 3

    ADDITIONAL INFORMATION WILL BE PROVIDED IN SUPPLEMENTAL MEDWATCH REPORT.

    Description of Event or Problem · 3

    CUSTOMER REPORTED THE MPA PIPETTED THE WRONG SAMPLE INTO THE INCORRECT CUPS. CUSTOMER STATES HE HAD THREE SPECIMENS THAT GAVE WRONG RESULTS COMPARED TO THE ORIGINAL TUBE. THE MPA PIPETTED THE SAMPLES AND THEY WERE SENT TO THE INSTRUMENT AND RUN, THE RESULTS DID NOT MATCH RESULTS FROM THE ORIGINAL TUBES. (THE TECH NOTICED THE RESULTS WERE HIGH. HE RAN THE SAMPLES FROM THE ORIGINAL TUBES AND GOT DIFFERENT RESULTS). HE CORRECTED THE RESULTS AND CALLED THE ER DOCTOR WITH THE RIGHT RESULTS, HE SAID THEY HAVE NO WAY OF KNOWING IF THE PATIENTS WERE TREATED. THE FOLLOWING RESULTS WERE PROVIDED, CUSTOMER WAS UNSURE WHICH COBAS ANALYZER SOME OF THESE REPEATS WERE TESTED ON. TWO DIFFERENT TYPES OF SAMPLE CONTAINERS ALL FROM SAME SAMPLE: SAMPLE 1 (MPA CUP, UNKNOWN COBAS), SODIUM 117 MMOL PER L (ACCOMPANIED BY LOW DATA FLAG), POTASSIUM 6.38 MMOL PER L (ACCOMPANIED BY HIGH DATA FLAG). SAMPLE 2 (ORIGINAL TUBE, UNKNOWN COBAS), SODIUM 137 MMOL PER L, POTASSIUM 3.4 MMOL PER L (ACCOMPANIED BY LOW DATA FLAG).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPA AUTOMATED PREANALYTICAL SYSTEM - LXG JJE ROCHE DIAGNOSTICS MPA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR
    2 18 YR
    3 59 YR