BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3439944 · Received October 31, 2013

    Report

    Report Number
    1823260-2013-06699
    Event Type
    Malfunction
    Date Received
    October 31, 2013
    Date of Event
    October 6, 2013
    Report Date
    November 22, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LEH
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE ISSUES FOUND BY THE FIELD SERVICE REPRESENTATIVE CAN EXPLAIN THE OBSERVED RESULTS. HOWEVER ,IT WAS NOTED THAT THE ERRONEOUS RESULTS WERE SIGNIFICANTLY TOO HIGH, BY A SIMILAR FACTOR. AN OPERATOR ERROR, SUCH AS INCORRECT CALIBRATION, COULD NOT BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. RESULTS: DEVICE SUBASSEMBLY- SAMPLE RINSE STATION.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS ON 85 PATIENT SAMPLES. OF THE DATA PROVIDED, IT WAS DETERMINED THAT 23 PATIENTS HAD ERRONEOUS RESULTS THAT HAD BEEN REPORTED OUTSIDE OF THE LABORATORY. OF THE 23 PATIENTS, IT WAS DETERMINED THAT 2 PATIENTS HAD RECEIVED TREATMENT BASED ON THE ERRONEOUS RESULTS THAT HAD BEEN REPORTED OUTSIDE OF THE LABORATORY. PATIENT 1 HAD AND INITIAL VANCOMYCIN (VANC) RESULT OF 13.7 UG/ML. THEIR VANCOMYCIN DOSAGE ADJUSTED FROM 1.0 MG "Q 8 HOURS" TO 1.25 MG "Q 6 HOURS" ON (B)(6) 2013. THIS DOSAGE WAS GIVEN UNTIL THE FOLLOWING DAY, WHEN THE LEVEL WAS CHECKED AND FOUND TO BE 32.1 UG/ML. THE SAMPLE FROM (B)(6) 2013 WAS REPEATED ON (B)(6) 2013 AND GENERATED A REPEAT RESULT OF 20.6 UG/ML. THE CUSTOMER INDICATED THE DOSE DID NOT BECOME TOXIC TO THE PATIENT. THE CUSTOMER HAD NO FURTHER INFORMATION ABOUT THIS PATIENT. PATIENT 2 HAD AN INITIAL TOTAL BILIRUBIN SPECIAL (TBIL) RESULT OF 17.5 MG/DL ON (B)(6) 2013. THE PATIENT WAS GIVEN AN ADDITIONAL MEDICATION WHICH DID NOT HARM HIM. THIS INFORMATION WAS OBTAINED BY THE CUSTOMER FROM THE PATIENT'S PHYSICIAN. THE SAMPLE WAS REPEATED ON (B)(6) 2013 AND GENERATED A REPEAT RESULT OF 11.6 MG/DL. THE CUSTOMER CAN PROVIDE NO FURTHER INFORMATION ON THIS PATIENT AND DOES NOT KNOW WHAT MEDICATION WAS GIVEN TO THE PATIENT. THIS PATIENT ALSO HAD AN INITIAL GLUCOSE HK (GLU) OF 147 MG/DL ON (B)(6) 2013. THE SAMPLE WAS REPEATED ON (B)(6) 2013 AND HAD A REPEAT RESULT OF 104 MG/DL. FOR THE DATA ON THE REMAINING 21 PATIENTS, PLEASE SEE THE ATTACHMENT TO THE MEDWATCH. THE LOT NUMBER OF ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (AST) REAGENT IN USE WAS 68315501, WITH AN EXPIRATION DATE OF 07/31/2014. THE LOT NUMBER OF TBIL REAGENT IN USE WAS 68256401, WITH AN EXPIRATION DATE OF 07/31/2014. THE LOT NUMBER OF CALCIUM (CA) REAGENT IN USE WAS 68826801, WITH AN EXPIRATION DATE OF 08/31/2014. THE LOT NUMBER OF C-REACTIVE PROTEIN GEN 3 (CRP) REAGENT IN USE WAS 68285201, WITH AN EXPIRATION DATE OF 08/31/2014. THE LOT OF DIGOXIN REAGENT IN USE WAS 68366401, WITH AN EXPIRATION DATE OF 04/30/2014. THE LOT OF GLU REAGENT IN USE WAS 68161501, WITH AN EXPIRATION DATE OF 07/31/2014. THE LOT OF PHOSPHATE (INORGANIC) VER2 (PHOS) REAGENT IN USE WAS 68092801, WITH AN EXPIRATION DATE OF 06/30/2014. THE LOT OF TOTAL PROTEIN GEN 2 (TP) REAGENT IN USE WAS 68369401, WITH AN EXPIRATION DATE OF 08/31/2014. THE LOT OF TINA-QUANT HEMOGLOBIN A1C GEN2 (HBA1C) REAGENT IN USE WAS 67339201, WITH AN EXPIRATION DATE OF 01/31/2014. THE LOT OF VANC REAGENT IN USE WAS 68237401, WITH AN EXPIRATION DATE OF 01/31/2014. THE FIELD SERVICE REPRESENTATIVE (FSR) WAS AT THE CUSTOMER SITE TWICE. ON (B)(6) 2013, THE FSR FOUND A FLUIDIC FAILURE OF THE SAMPLE PROBE RINSE STATION AND THAT THE RINSE STATION WAS CLOGGED. HE CLEANED THE SAMPLE RINSE TUBING. THE CUSTOMER PERFORMED QC, WHICH WAS WITHIN THEIR SPECIFICATIONS. THE FSR RETURNED ON (B)(6) 2013 AND CHECKED FOR PROPER DRAINING AND HE ALSO INCREASED THE SAMPLE RINSE FLOW. THE CUSTOMER HAS RUN THE INSTRUMENT WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559890 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER LEH ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1