BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREA PREALBUMIN

    MDR report key: 7130650 · Received December 19, 2017

    Report

    Report Number
    1823260-2017-03026
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    December 4, 2017
    Report Date
    January 17, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZJ
    PMA / PMN Number
    K972638
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION WAS NOT ABLE TO DETERMINE A ROOT CAUSE. THERE HAVE NOT BEEN ADDITIONAL SERVICE VISITS RELATED TO THE ISSUE.

    Additional Manufacturer Narrative · 1

    BASED ON REVIEW OF THE PROVIDED CALIBRATION TRACE, MULTIPLE CALIBRATIONS WERE ACCOMPANIED WITH DATA FLAGS. REVIEW OF THE PROVIDED DATA DID SHOW THAT THE QUALITY CONTROL WAS AT THE UPPER RANGE ON (B)(6) 2017.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER DISCOVERED QUESTIONABLE PREA PREALBUMIN (PAB) RESULTS HAD BEEN GENERATED WHEN THEY PERFORMED A REAGENT LOT CORRELATION. THE RESULTS USING THE PREVIOUS REAGENT LOT WERE HIGHER THAN THE RESULTS USING THAT REAGENT LOT AND A NEW REAGENT LOT FROM A DIFFERENT ANALYZER. OF THE DATA PROVIDED FOR TWO EXAMPLES, ONLY THE RESULTS FOR ONE EXAMPLE WERE DISCREPANT. THE INITIAL RESULT WAS 75 MG/DL WITH THE OLD REAGENT LOT. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2017, THE RESULT WAS 19 MG/DL FOR THE SAME SAMPLE WITH THE PREVIOUS REAGENT LOT AND WITH THE NEW REAGENT LOT ON A DIFFERENT ANALYZER. THE CUSTOMER CORRECTED THE RESULT ON (B)(6) 2017. THE CUSTOMER DID NOT KNOW OF ANY ADVERSE EVENT FOR THE PATIENT. THE PREVIOUS REAGENT LOT NUMBER WAS 19429601 WITH AN EXPIRATION DATE OF 31-JUL-2018. THE NEW REAGENT LOT NUMBER WAS 24913401 WITH AN EXPIRATION DATE OF 31-MAR-2019. THE FIELD SERVICE ENGINEER (FSE) COULD NOT FIND A CAUSE. HE CHECKED THE PROBE ADJUSTMENT AND RINSE MECHANISM FLUID LEVELS AND PERFORMED A PRECISION CHECK FOR PAB THAT WAS WITHIN SPECIFICATION. HE CALIBRATED AND RAN QUALITY CONTROL THAT WAS WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910987 PREA PREALBUMIN CLINICAL CHEMISTRY ANALYZER JZJ ROCHE DIAGNOSTICS C502 19429601

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR