BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBUMIN

    MDR report key: 2492616 · Received March 15, 2012

    Report

    Report Number
    1823260-2012-01441
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    March 1, 2012
    Report Date
    May 22, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CIX
    PMA / PMN Number
    K033009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. INVESTIGATIONS CONCLUDE THAT THERE IS NO EVIDENCE CONNECTING THE PLASTIC PARTICLES IN THE BOTTLE AND THE OBSERVED DISCREPANT RESULTS. NO REAGENT NOR PACKAGING ABNORMALITY IS RESPONSIBLE FOR THE OBSERVED OUTLIERS. THE ISSUE COULD NOT BE REPRODUCED. THERE IS NO GENERAL ISSUE AT THE CUSTOMER SITE AND THE PROBLEM DID NOT RECUR AFTER REAGENT BOTTLE CHANGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD QUESTIONABLE RESULTS FOR TWENTY FIVE PATIENT SAMPLES TESTED FOR ALBUMIN BCG METHOD (ALBUMIN). OF THE TWENTY FIVE PATIENT SAMPLES, THE CUSTOMER PROVIDED RESULTS FOR TEN PATIENT SAMPLES. ALL TEN PATIENT SAMPLES WERE FOUND TO HAVE ERRONEOUS RESULTS. ALL INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. A FLOOR NURSE QUESTIONED THE HIGH INITIAL ALBUMIN RESULTS WHICH CAUSED THE CUSTOMER TO PULL AND REPEAT THE ALBUMINS. ALL REPEAT RESULTS WERE CONSIDERED TO BE CORRECT AND CORRECTED REPORTS WERE ISSUED FOR THE REPEATS OF ALL 25 PATIENT SAMPLES. SAMPLE ONE INITIALLY RESULTED AS 6.47 G/DL AND REPEATED AS 3.63 G/DL. SAMPLE TWO INITIALLY RESULTED AS 6.69 G/DL AND REPEATED AS 4.49 G/DL. SAMPLE THREE INITIALLY RESULTED AS 6.40 G/DL AND REPEATED AS 3.93 G/DL. SAMPLE FOUR INITIALLY RESULTED AS 6.59 G/DL AND REPEATED AS 2.99 G/DL. SAMPLE FIVE INITIALLY RESULTED AS 6.66 G/DL AND REPEATED AS 3.69 G/DL. SAMPLE SIX INITIALLY RESULTED AS 6.54 G/DL AND REPEATED AS 3.66 G/DL. SAMPLE SEVEN INITIALLY RESULTED AS 6.52 G/DL AND REPEATED AS 3.78 G/DL. SAMPLE EIGHT INITIALLY RESULTED AS 6.52 G/DL AND REPEATED AS 3.18 G/DL. SAMPLE NINE INITIALLY RESULTED AS 6.38 G/DL AND REPEATED AS 3.97 G/DL. SAMPLE TEN INITIALLY RESULTED AS 6.67 G/DL AND REPEATED AS 3.82 G/DL. THE PATIENTS WERE NOT ADVERSELY AFFECTED BY THE EVENT. THE ANALYZER WAS AN ANALYTICAL P MODULE WITH SERIAL NUMBER (B)(4). THE CUSTOMER DECLINED A SERVICE VISIT AND STATED THAT THE REAGENT BOTTLE HAD WHAT APPEARED TO BE PLASTIC PIECES THROUGHOUT THE ENTIRE BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALBUMIN BROMCRESOL GREEN DYE-BINDING, ALBUMIN CIX ROCHE DIAGNOSTICS NA 64741801

    Patients

    Seq Age Sex Outcome Treatment
    1