BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 7224254 · Received January 29, 2018

    Report

    Report Number
    1823260-2018-00251
    Event Type
    Malfunction
    Date Received
    January 29, 2018
    Date of Event
    December 4, 2017
    Report Date
    January 29, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR THE ELECSYS PTH IMMUNOASSAY (PTH) ON A COBAS 6000 E 601 MODULE (E601). AN ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 32 PG/ML. THE SAMPLE WAS REPEATED TWICE ON (B)(6) 2017, RESULTING AS 31.75 PG/ML AND 112.5 PG/ML. THE 112.5 PG/ML WAS BELIEVED TO BE CORRECT AND A CORRECTED REPORT WAS ISSUED FOR THIS VALUE. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE PTH REAGENT LOT NUMBER WAS 220377. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER CHECKED THE PROBES, PROBE ADJUSTMENTS, AND ALL SYRINGES. HE REPLACED ALL PINCH TUBING AS THESE WERE WORN OUT. HE RAN PERFORMANCE TESTING AND THIS WAS SUCCESSFUL. A CALIBRATION PERFORMED ON (B)(6) 2017 WAS SLIGHTLY BELOW EXPECTED RANGES. A CALIBRATION PERFORMED ON (B)(6) 2017 WAS WITHIN EXPECTED RANGE FOR ONE CALIBRATOR LEVEL, BUT SLIGHTLY BELOW THE EXPECTED RANGE FOR THE SECOND CALIBRATOR LEVEL. QUALITY CONTROLS TESTED ON (B)(6) 2017 WERE WITHIN RANGE. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. A GENERAL REAGENT ISSUE COULD BE EXCLUDED. POSSIBLE ROOT CAUSES FOR THIS EVENT MAY BE THE WORN PINCH TUBING, SAMPLE QUALITY, AND INSUFFICIENT MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69840 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR