BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1241670 · Received November 19, 2008

    Report

    Report Number
    1823260-2008-08557
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED THEY DO NOT WANT TO CHANGE THE TYPE OF SAMPLE TUBES AT THIS TIME, AND ARE MANUALLY VERIFYING ALL RESULTS BEFORE THEY ARE RELEASED SO NO ERRONEOUS RESULTS ARE SENT OUT.

    Description of Event or Problem · 1

    USER RECEIVING MULTIPLE PT SAMPLES GENERATING INTERMITTENT ZERO AND DISCREPANT RESULTS FROM MULTIPLE ASSAYS. EXACT NUMBER OF PT SAMPLES IMPACTED NOT PROVIDED. THE FOLLOWING TWO PT EXAMPLES WERE PROVIDED. SAMPLE 1 REPEATED TWICE: SAMPLE 2 REPEATED ONCE. INITIAL ALBUMIN GAVE 3.4 G/DL, REPEATS GAVE 0.0 AND 3.4 G/DL. INITIAL CALCIUM GAVE 8.4 MG/DL; REPEATS GAVE 0.0 AND 8.5 MG/DL. INITIAL BICARBONATE GAVE 23 MMOL/L; REPEATS GAVE 0 AND 23 MMOL/L. INITIAL GLUCOSE GAVE 0 MG/DL; REPEATS GAVE 86 AND 83 MG/DL. CUSTOMER DECLINED A FIELD SERVICE DISPATCH, STATING THEY BELIEVE THE CAUSE TO BE THE TYPE OF SAMPLES TUBES THEY ARE USING, WHICH ALLOW CLOTS TO FORM IN THE SAMPLES. CUSTOMER IS PERFORMING A DAILY PIPE AND CLEANING THE SAMPLE PROBES TO RESOLVE THE ISSUE.

    Description of Event or Problem · 2

    USER RECEIVING MULTIPLE PT SAMPLES GENERATING INTERMITTENT ZERO AND DISCREPANT RESULTS FROM MULTIPLE ASSAYS. EXACT NUMBER OF PT SAMPLES IMPACTED NOT PROVIDED. THE FOLLOWING TWO PT EXAMPLES WERE PROVIDED. SAMPLE 1 REPEATED TWICE: SAMPLE 2 REPEATED ONCE. INITIAL ALK PHOSPHORUS GAVE -1 U/L; REPEAT GAVE 102 U/L. INITIAL CK GAVE 1 U/L; REPEAT GAVE 204 U/L. INITIAL GLUCOSE GAVE 0 MG/DL; REPEAT GAVE 83 MG/DL. CUSTOMER DECLINED A FIELD SERVICE DISPATCH, STATING THEY BELIEVE THE CAUSE TO BE THE TYPE OF SAMPLE TUBES THEY ARE USING, WHICH ALLOW CLOTS TO FORM IN THE SAMPLES. CUSTOMER IS PERFORMING A DAILY PIPE AND CLEANING THE SAMPLE PROBES TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER - CEM CEM ROCHE DIAGNOSTICS C501

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR
    2 42 YR