BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-01519

    MDR report key: 6737245 · Received July 24, 2017

    Report

    Report Number
    1823260-2017-01519
    Event Type
    Malfunction
    Date Received
    July 24, 2017
    Date of Event
    June 29, 2017
    Report Date
    July 24, 2017
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4). INITIAL REPORTER PHONE NUMBER WAS PROVIDED AS "(B)(6)".

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED FOR MULTIPLE ASSAYS ON THE COBAS 6000 C (501) MODULE - C501. THE CUSTOMER PROVIDED DATA FOR A TOTAL OF 23 PATIENT SAMPLES AND OF THESE, 13 HAD ERRONEOUS RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY FOR CHOL2 CHOLESTEROL GEN.2 (CHOL), TRIGL TRIGLYCERIDES (TRIG), AND LDL_C LDL-CHOLESTEROL PLUS 3RD GENERATION (LDL). THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIELD SERVICE ENGINEER CHECKED RINSE PRESSURES AND REACTION CELL FILL LEVELS. THE ENGINEER PERFORMED SEVERAL PROBE PURGES. THE PROBE WAS BLOCKED, SO IT WAS CHANGED. THE CUSTOMER THEN RAN QUALITY CONTROLS AND THESE WERE WITHIN RANGE. THE SAMPLES WERE REPEATED AFTER THE SERVICE ACTIVITIES WERE PERFORMED AND THE REPEAT RESULTS WERE CONSIDERED TO BE CORRECT. NO ADVERSE EVENTS WERE ALLEGED. THE CHOL REAGENT LOT NUMBER WAS 236242. THE TRIG REAGENT LOT NUMBER WAS 236112. THE LDL REAGENT LOT NUMBER WAS 173247. THE REAGENT EXPIRATION DATES WERE ASKED FOR, BUT NOT PROVIDED.

    Patients

    Seq Age Sex Outcome Treatment
    1