BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 3251877 · Received July 29, 2013

    Report

    Report Number
    1823260-2013-04513
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 10, 2013
    Report Date
    September 9, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LEH
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. A CRACKED PIPETTE MODULE DISTRIBUTOR BLOCK MAY CAUSE SPORADIC OUTLIERS DUE TO PIPETTING OF AIR.

    Additional Manufacturer Narrative · 1

    THE PHARMACIST INDICATED THAT THE REPEAT RESULT OF THE ORIGINAL SAMPLE AT THE TIME IT WAS DRAWN WAS MORE CONSISTENT WITH THE DOSAGE THERAPY.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. RESULTS: PIPETTE MODULE DISTRIBUTOR BLOCK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR VANCOMYCIN. THE SAMPLE WAS A TROUGH SAMPLE. THE SAMPLE INITIALLY RESULTED AS 49.9 UG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHARMACIST QUESTIONED THE RESULT, SO A NEW SAMPLE WAS THEN DRAWN FROM THE PATIENT. THE NEW SAMPLE RESULTED AS 9.8 UG/ML. THE CUSTOMER THEN PULLED THE ORIGINAL SAMPLE AND THIS SAMPLE WAS REPEATED ON (B)(6) 2013, RESULTING AS 13.3 UG/ML. THE ORIGINAL SAMPLE WAS REPEATED A SECOND TIME ON (B)(6) 2013, USING A NEW REAGENT CASSETTE FROM THE SAME LOT AND RESULTED AS 13.9 UG/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT AND A CORRECTED REPORT WAS ISSUED FOR THE REPEAT VALUE. THE NEW SAMPLE WAS ALSO REPEATED AND RESULTED AS 9.9 UG/ML. ON (B)(6) 2013, THE PATIENT'S VANCOMYCIN DOSAGE WAS 1000 MG "IV" EVERY 12 HOURS. AFTER RECEIVING THE INITIAL HIGH VANCOMYCIN RESULT ON (B)(6) 2013, THE PATIENT'S DOSAGE WAS LOWERED TO 1000 MG DAILY. TREATMENT WAS WITHHELD UNTIL A CORRECTED REPORT WAS ISSUED WITH THE REPEAT VALUE ON (B)(6) 2013. AFTER RECEIVING THE CORRECTED REPORT ON (B)(6) 2013, THE DOSAGE WAS INCREASED TO 1250 MG EVERY 12 HOURS. THE CUSTOMER IS NOT AWARE OF ANY ADVERSE EFFECTS TO THE PATIENT BASED ON THE TREATMENT PROVIDED AND THE CUSTOMER IS NOT CERTAIN IF THE PATIENT HAS BEEN RELEASED. NO ADVERSE EVENTS WERE ALLEGED. THE VANCOMYCIN REAGENT LOT NUMBER IS 67476101 WITH AN EXPIRATION DATE OF 04/30/2014. THE CUSTOMER FOUND THE ORIGINAL SAMPLE TO BE SLIGHTLY ICTERIC. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THERE WAS A CRACKED PIPETTE MODULE DISTRIBUTOR BLOCK. HE REPLACED THE PIPETTE MODULE DISTRIBUTOR BLOCK, REPLACED THE SYRINGE SEALS, AND REPLACED THE PROBES. HE RAN A CHECK TEST AND ALL CHECKS PASSED. THE CUSTOMER RAN QUALITY CONTROLS AND THESE WERE WITHIN CORRECT RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353312 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER LEH ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 080 YR REFER TO ATTACHMENT TO MEDWATCH FOR MEDICATIONS