BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2914199 · Received January 14, 2013

    Report

    Report Number
    1823260-2013-00281
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 14, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS ON CALCIUM GEN 2 (CA), CREATININE JAFFE GEN 2 (CREA), GLUCOSE HK (GLU), TOTAL PROTEIN GEN 2 (TP), AND UREA/BUN (BUN) FOR 14 PATIENTS. ALL RESULTS ARE IN MG/DL; EXCEPT FOR TP, WHICH IS IN G/DL. PATIENT 1 HAD AN ORIGINAL GLU RESULT OF 235 AND AN ORIGINAL CREA RESULT OF 1.95. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501, SERIAL NUMBER (B)(4) AND GENERATED A GLU RESULT OF 106, ACCOMPANIED BY A DATA FLAG; AND A REPEAT CREA RESULT OF 0.45, ACCOMPANIED BY A DATA FLAG. PATIENT 2, A (B)(6) FEMALE: HAD AN ORIGINAL GLU RESULT OF 237 AND AN ORIGINAL CA RESULT OF 5.7. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501, SERIAL NUMBER (B)(4) AND GENERATED A GLU RESULT OF 110, ACCOMPANIED BY A DATA FLAG; AND A REPEAT CA RESULT OF 7.6, ACCOMPANIED BY A DATA FLAG. PATIENT 3, A (B)(6) FEMALE, DATE OF BIRTH: (B)(6): HAD AN ORIGINAL GLU RESULT OF 266 AND AN ORIGINAL TP RESULT OF 7.5. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501, SERIAL NUMBER (B)(4) AND GENERATED A GLU RESULT OF 120, ACCOMPANIED BY A DATA FLAG; AND A REPEAT TP RESULT OF 6.3. PATIENT 4, A (B)(6) MALE, DATE OF BIRTH: (B)(6): HAD AN ORIGINAL GLU RESULT OF 352, AN ORIGINAL CREA RESULT OF 4.02, AN ORIGINAL TP RESULT OF 7.9 AND AN ORIGINAL CA RESULT OF 11.4. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501, SERIAL NUMBER (B)(4) AND GENERATED A GLU RESULT OF 165, ACCOMPANIED BY A DATA FLAG, A REPEAT CREA RESULT OF 1.30, A REPEAT TP RESULT OF 6.6, AND A REPEAT CA RESULT OF 8.6. PATIENT 5, A (B)(6) MALE: HAD AN ORIGINAL GLU RESULT OF 291, AND AN ORIGINAL CREA RESULT OF 4.99. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501, SERIAL NUMBER (B)(4) AND GENERATED A GLU RESULT OF 136, ACCOMPANIED BY A DATA FLAG; AND A REPEAT CREA RESULT OF 1.74, ACCOMPANIED BY A DATA FLAG. PATIENT 6, A (B)(6) FEMALE: HAD AN ORIGINAL TP RESULT OF 6.7. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501, SERIAL NUMBER (B)(4) AND GENERATED A TP RESULT OF 5.6, ACCOMPANIED BY A DATA FLAG. PATIENT 7, A (B)(6) MALE: HAD AN ORIGINAL GLU RESULT OF 218. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501, SERIAL NUMBER (B)(4) AND GENERATED A GLU RESULT OF 104, ACCOMPANIED BY A DATA FLAG. PATIENT 8, A (B)(6) FEMALE: HAD AN ORIGINAL GLU RESULT OF 289, AN ORIGINAL BUN RESULT OF 44, AN ORIGINAL CREA RESULT OF 2.95, AND AN ORIGINAL CA RESULT OF 13.1. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501, SERIAL NUMBER (B)(4) AND GENERATED A GLU RESULT OF 134, ACCOMPANIED BY A DATA FLAG, A REPEAT BUN RESULT OF 29, ACCOMPANIED BY A DATA FLAG, A REPEAT CREA RESULT OF 0.82 AND A REPEAT CA RESULT OF 8.7. PATIENT 9, A (B)(6) FEMALE: HAD AN ORIGINAL GLU RESULT OF 189 AND AN ORIGINAL CREA RESULT OF 2.51. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501, SERIAL NUMBER (B)(4) AND GENERATED A GLU RESULT OF 90, AN A REPEAT CREA RESULT OF 0.76. PATIENT 10, A (B)(6) FEMALE: HAD AN ORIGINAL GLU RESULT OF 261 AND AN ORIGINAL CREA RESULT OF 2.84. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501, SERIAL NUMBER (B)(4) AND GENERATED A GLU RESULT OF 125, ACCOMPANIED BY A DATA FLAG, AND A REPEAT CREA RESULT OF 0.84. PATIENT 11, A (B)(6) MALE: HAD AN ORIGINAL GLU RESULT OF 253 AND AN ORIGINAL CREA RESULT OF 3.54. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501, SERIAL NUMBER (B)(4) AND GENERATED A GLU RESULT OF 114, ACCOMPANIED BY A DATA FLAG, AND A REPEAT CREA RESULT OF 1.18. PATIENT 12, A (B)(6) FEMALE: HAD AN ORIGINAL GLU RESULT OF 441 AND AN ORIGINAL CREA RESULT OF 2.88. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501, SERIAL NUMBER (B)(4) AND GENERATED A GLU RESULT OF 224, ACCOMPANIED BY A DATA FLAG, AND A REPEAT CREA RESULT OF 0.84. PATIENT 13, A (B)(6) FEMALE, DATE OF BIRTH: (B)(6): HAD AN ORIGINAL GLU RESULT OF 221, AN ORIGINAL CREA RESULT OF 2.99 AND AN ORIGINAL CA RESULT OF 5.6. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501, SERIAL NUMBER (B)(4) AND GENERATED A GLU RESULT OF 119, ACCOMPANIED BY A DATA FLAG, A REPEAT CREA RESULT OF 0.87 AND A REPEAT CA RESULT OF 9.0. PATIENT 14, A (B)(6) MALE: HAD AN ORIGINAL CA RESULT OF 7.2. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501, SERIAL NUMBER (B)(4) AND GENERATED A CA RESULT OF 8.7. IT IS UNKNOWN WHAT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DEEMED THE REPEAT RESULTS TO BE THE CORRECT RESULTS. THERE WAS NO ADVERSE EVENT. THE LOT OF GLU REAGENT IN USE WAS UNKNOWN. THE LOT OF CREA REAGENT IN USE WAS 66678901, WITH AN EXPIRATION DATE OF 04/30/2014. THE LOT OF CA REAGENT IN USE WAS UNKNOWN. THE LOT OF TP REAGENT IN USE WAS UNKNOWN. THE LOT OF BUN REAGENT IN USE WAS UNKNOWN. THE FIELD SERVICE REPRESENTATIVE FOUND A PROBLEM WITH THE REAGENT VALVE, AND A PROBLEM WITH THE DETERGENT CHECK VALVE. THE VALVES WERE REPLACED. HE VERIFIED THE VALVES WORKED UPON STARTING THE ANALYZER. THE CUSTOMER PERFORMED QC, WHICH WAS WITHIN EXPECTED RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21594 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 041 YR