BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-02343

    MDR report key: 6954108 · Received October 17, 2017

    Report

    Report Number
    1823260-2017-02343
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    October 3, 2017
    Report Date
    November 1, 2017
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS RESOLVED WITH THE REPLACEMENT OF THE WORN RINSE TUBING.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)# (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF AN ISSUE WITH THEIR COBAS 8000 C 702 MODULE. THE CUSTOMER FIRST NOTICED A PROBLEM WITH THE ANALYZER WHEN THEIR CONTROLS FOR ALB2 ALBUMIN GEN.2 WERE OUT OF RANGE. THE CUSTOMER DID NOT PROVIDE ANY SPECIFIC ALBUMIN PATIENT RESULTS AND THERE WAS NO INDICATION OF ANY PATIENTS BEING AFFECTED BY THE ALBUMIN RESULTS OBTAINED. THE FIELD ENGINEERING SPECIALIST FOUND DAMAGED TUBING ON THE CELL RINSE MECHANISM THAT WAS LEADING TO LEAKING INTO THE REACTION CELLS. HE FIXED THE DAMAGED TUBING AND OBSERVED THE ANALYZER WAS FUNCTIONING CORRECTLY. THE CUSTOMER PERFORMED CALIBRATION AND QC WHICH ALL WAS IN RANGE. THE CUSTOMER THEN REPEATED PATIENT SAMPLES AND PROVIDED THE HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION (HDLC3) RESULTS FOR TWO PATIENTS OF WHICH BOTH ARE A REPORTABLE MALFUNCTION. FOR PATIENT #1 THE INITIAL HDLC3 RESULT WAS 143 MG/DL WITH A REPEAT RESULT OF 39 MG/DL. FOR PATIENT #2 THE INITIAL HDLC3 RESULT WAS 151 MG/DL WITH A REPEAT RESULT OF 45 MG/DL. THE INITIAL RESULTS FOR HDLC3 WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT AND CORRECTED REPORTS HAD TO BE ISSUED. THE CUSTOMER WAS UNSURE IF THERE WERE ANY ADVERSE EVENTS AND SAID HE WOULD NOT BE ABLE TO FIND OUT FOR SURE. THERE WAS NO PATIENT INFORMATION PROVIDED BY THE CUSTOMER. THE HDL-CHOLESTEROL REAGENT LOT WAS 200769 WITH AN EXPIRATION DATE THAT WAS REQUESTED BUT NOT PROVIDED. THE SAMPLES WERE ALIQUOTED BY A MODULAR PRE-ANALYTICS SYSTEM.

    Patients

    Seq Age Sex Outcome Treatment
    1