BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAMIN B12

    MDR report key: 3763507 · Received April 22, 2014

    Report

    Report Number
    1823260-2014-02923
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 31, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDD
    PMA / PMN Number
    K060755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THE DIFFERENCES IN THE PATIENT RESULTS SEEN BY THE CUSTOMER WERE RELATED TO A KNOWN ISSUE COVERED IN A PRODUCT BULLETIN. ROCHE HAS CONFIRMED THAT THE ELECSYS VITAMIN B12 REAGENT, LOT NUMBERS 172593 AND 174159 RECOVER SLIGHTLY HIGHER THAN PREVIOUS LOTS BUT STILL WITHIN THE SPECIFIED RANGE. AS A RESULT, THE NEWEST LOT OF VITAMIN B12, 175380, WAS ADJUSTED TO RECOVER LOWER, SIMILAR TO LOTS MADE PRIOR TO LOT NUMBER 172593. THERE IS NO RISK ASSOCIATED WITH ANY CURRENTLY AVAILABLE LOTS OF VITAMIN B12, AS THEY ALL PERFORM WITHIN PRODUCT RELEASE SPECIFICATIONS. RECOVERY WITH NATIVE PATIENT SAMPLES WAS WITHIN SPECIFICATION. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE VITAMIN B12 RESULTS ON THEIR E601 ANALYZER. THE CUSTOMER ALLEGED THEY RECEIVED A SHIFT IN THEIR QUALITY CONTROL RESULTS AND A VERY BIG SHIFT IN RESULTS ON PATIENT SAMPLES WHEN THEY USED A NEW LOT OF REAGENT. THE CUSTOMER REPEATED THE PATIENT SAMPLES ON (B)(6) 2014 AND OBTAINED VALUES MUCH LOWER THAN THE INITIAL RESULTS. THE CUSTOMER PROVIDED RESULTS FOR 50 PATIENTS, THREE OF WHICH HAD DISCREPANT RESULTS. THE FIRST PATIENT'S INITIAL VITAMIN B12 RESULT WAS 422.5 PG/ML. THE REPEAT RESULT WAS 275.1 PG/ML. THE SECOND PATIENT'S INITIAL VITAMIN B12 RESULT WAS 431.2 PG/ML. THE REPEAT RESULT WAS 281.9 PG/ML. THE THIRD PATIENT'S INITIAL VITAMIN B12 RESULT WAS 185.1 PG/ML. THE REPEAT RESULT WAS 107.1 PG/ML ACCOMPANIED BY A DATA FLAG. INFORMATION ON WHETHER THE DISCREPANT RESULTS WERE REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT NOT PROVIDED. THERE WERE NO DEATHS, INJURIES, ILLNESSES, OR DETERIORATIONS IN HEALTH ASSOCIATED WITH THE ERRONEOUS RESULTS. INFORMATION ON WHETHER THE PATIENT WAS HARMED BY ANY ACTION TAKEN WAS REQUESTED BUT NOT PROVIDED. THE VITAMIN B12 REAGENT LOT NUMBER WAS 175380. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243485 VITAMIN B12 RADIOASSAY, VITAMIN B12 CDD ROCHE DIAGNOSTICS NA 175380

    Patients

    Seq Age Sex Outcome Treatment
    1