BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 6696870 · Received July 10, 2017

    Report

    Report Number
    1823260-2017-01423
    Event Type
    Malfunction
    Date Received
    July 10, 2017
    Date of Event
    June 20, 2017
    Report Date
    August 13, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. POSSIBLE ROOT CAUSES INCLUDE THE HANDLING OF A SYSTEM REAGENT, OR CONTAMINATION OF THE MEASURING CELL BY IMPROPER SAMPLE MATERIAL. A GENERAL ISSUE WITH THE SYSTEM REAGENT IS NOT LIKELY SINCE THERE HAVE BEEN NO OTHER SIMILAR EVENTS AT THE CUSTOMER SITE. NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER NOTICED THAT THEY WERE GETTING RESULTS OF > 320 NMOL/L FOR THE ELECSYS T4 ASSAY (T4) ON THE COBAS 6000 E 601 MODULE (E601). AFTER THREE OF THESE RESULTS WERE NOTICED, THE CUSTOMER BECAME SUSPICIOUS AND STOPPED TESTING OF THIS ASSAY BY MASKING THE TEST ON THE ANALYZER. THE CUSTOMER PERFORMED LIQUID FLOW CLEANING MAINTENANCE THREE TIMES FOLLOWED BY 50 MEASURING CELL PREPARATION CYCLES. THE CUSTOMER REPEATED QUALITY CONTROLS AFTER THIS AND THEY WERE FINE. THE CUSTOMER THEN REPEATED SAMPLES FROM THE START OF THE DAY TO THE TIME WHEN THE TEST WAS MASKED. THE SAMPLES WERE REPEATED ON A DIFFERENT ANALYZER. THE RESULTS WERE THEN CORRECTED AND THE AFFECTED DEPARTMENTS WERE CONTACTED. THE CUSTOMER PROVIDED DATA FOR A TOTAL OF 30 PATIENT SAMPLES TESTED FOR MULTIPLE ASSAYS AND REPEATED. OF THESE 30 SAMPLES, 29 HAD ERRONEOUS RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY FOR T4, THE ELECSYS PTH IMMUNOASSAY (PTH), ELECSYS FERRITIN (FERR), ELECSYS T3 (T3), THE ELECSYS TSH ASSAY (TSH), AND THE ELECSYS T-UPTAKE ASSAY (T-UP). REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENTS. THE FOLLOWING REAGENT LOT NUMBERS WERE USED: T3 = LOT 198297, T4 = LOT 194281, TSH = LOT 226376, T-UP = LOT 163357, PTH = LOT 220377, FERR = LOT 192154. THE REAGENT EXPIRATION DATES WERE ASKED FOR, BUT NOT PROVIDED. THE CUSTOMER PERFORMED ADDITIONAL QUALITY CONTROL TESTING ON (B)(6) 2017; CONTROLS RECOVERED OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478084 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1