BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 3233971 · Received July 18, 2013

    Report

    Report Number
    1823260-2013-04346
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 30, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    WHEN ASKED TO PROVIDE INFORMATION REGARDING THE GENDERS OF THE PATIENTS INVOLVED, THE CUSTOMER ONLY PROVIDED THAT ONE OF THE (B)(6) PATIENTS WAS MALE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY OBTAINED QUESTIONABLE RESULTS ON SEVEN PATIENT SAMPLES TESTED FOR TROPONIN I STAT (SHORT TURN AROUND TIME), (TNI). OF THE SEVEN SAMPLES, ALL HAD ERRONEOUS RESULTS; THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. ON THE MORNING OF (B)(6) 2013 THE CUSTOMER PERFORMED CONTROLS FOR ALL CARDIAC MARKERS, MYOGLOBIN, CKMB, TNI, AND HCG STAT. ALL RESULTS WERE IN THE ACCEPTABLE RANGE. IN THE AFTERNOON THE CUSTOMER REPEATED CONTROLS AND FOUND THEM OUT OF RANGE, LOW. SINCE THE CONTROLS WERE OUT OF RANGE THE CUSTOMER DECIDED TO REPEAT SOME SAMPLES. SEVEN OF THE PATIENTS HAD DISCREPANT RESULTS FOR TNI. THE CUSTOMER FOUND NO DISCREPANCIES FOR THE OTHER ASSAYS. EACH OF THE SEVEN SAMPLES WAS MEASURED THREE TIMES. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY IN EACH CASE. THE CUSTOMER BELIEVED THE SECOND REPEAT RESULT IN EACH CASE TO BE CORRECT. THE SECOND REPEAT RESULTS WERE ALL OBTAINED BETWEEN 6 AND 7 AM ON (B)(6) 2013. THE CUSTOMER WAS ASKED TO PROVIDE THE UNITS OF MEASURE FOR THE ASSAY, BUT DID NOT. PATIENT 1 HAD AN INITIAL TNI OF 0.273. THE FIRST REPEAT RESULT WAS 0.280. THE SECOND REPEAT WAS < 0.100. PATIENT 2, A (B)(6), HAD AN INITIAL TNI OF 0.167. THE FIRST REPEAT RESULT WAS 0.207. THE SECOND REPEAT WAS < 0.100. PATIENT 3, A (B)(6), HAD AN INITIAL TNI OF 0.229. THE FIRST REPEAT RESULT WAS 0.273. THE SECOND REPEAT WAS < 0.100. PATIENT 4, A (B)(6), HAD AN INITIAL TNI OF 0.280. THE FIRST REPEAT RESULT WAS 0.286. THE SECOND REPEAT WAS < 0.100. PATIENT 5, A (B)(6), HAD AN INITIAL TNI OF 0.317. THE FIRST REPEAT RESULT WAS 0.339. THE SECOND REPEAT WAS < 0.100. PATIENT 6, A (B)(6), HAD AN INITIAL TNI OF 0.334. THE FIRST REPEAT RESULT WAS 0.371. THE SECOND REPEAT WAS < 0.100. PATIENT 7, A (B)(6), HAD AN INITIAL TNI OF 0.310. THE FIRST REPEAT RESULT WAS 0.388. THE SECOND REPEAT WAS < 0.100. THE INITIAL RESULT ON THIS SAMPLE WAS OBTAINED AT 00:00 AM ON (B)(6) 2013. WHEN ASKED TO PROVIDE INFORMATION REGARDING ANY DEATHS OR SERIOUS INJURIES, THE CUSTOMER ONLY STATED THE PATIENTS STAYED OVERNIGHT FOR OBSERVATION. THE APPLICATION SPECIALIST AND ENGINEER VISITED THE SITE. THE APPLICATION SPECIALIST FOUND FOAM IN SOME REAGENT PACKS. THE ENGINEER FOUND A BEAD MIXER MISFIT. HE ADJUSTED THE MIXER. THE APPLICATION SPECIALIST PERFORMED A PRECISION TEST ON TNI AND RELEASED THE SYSTEM FOR ROUTINE USE. THE LOT NUMBER OF TNI REAGENT IN USE WAS 170260. THE CUSTOMER WAS ASKED FOR THE EXPIRATION DATE OF THE REAGENT BUT DID NOT PROVIDE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333704 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER MMI ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 065 YR