BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAMIN B12

    MDR report key: 2072867 · Received April 29, 2011

    Report

    Report Number
    1823260-2011-02319
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDD
    PMA / PMN Number
    K060755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER EXPERIENCED AN ISSUE WITH CALIBRATION FOR VITAMIN B12 AND RECEIVED QUESTIONABLE RESULTS FOR APPROXIMATELY 36 PATIENT SAMPLES FROM THE ELECSYS 2010 DISK ANALYZER SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THE RESULTS FOR 16 PATIENT SAMPLES WERE DISCREPANT. ALL INITIAL RESULTS WERE GENERATED ON (B)(6) 2011 AND THE REPEAT TESTING WAS PERFORMED ON (B)(6) 2011. ALL RESULTS ARE IN PG/ML. PATIENT SAMPLE 1 INITIAL RESULTS WERE 237 (236.8) WITH A DATA FLAG AND 348. THE REPEAT RESULT WAS 440. PATIENT SAMPLE 2 WAS FROM A (B)(6) MALE. THE INITIAL RESULT WAS 65 (64.69) WITH A DATA FLAG AND THE REPEAT RESULT WAS 194. PATIENT SAMPLE 3 WAS FROM A (B)(6) FEMALE. THE INITIAL RESULT WAS 337 (337.1) AND THE REPEAT RESULT WAS 575. PATIENT SAMPLE 4 WAS FROM A (B)(6) FEMALE. THE INITIAL RESULT WAS 242 AND THE REPEAT RESULT WAS 455. PATIENT SAMPLE 5 WAS FROM A (B)(6) FEMALE. THE INITIAL RESULT WAS 343 (342.6) AND THE REPEAT RESULT WAS 564. PATIENT SAMPLE 6 WAS FROM A (B)(6) FEMALE. THE INITIAL RESULT WAS 104(104.2) WITH A DATA FLAG AND THE REPEAT RESULT WAS 272. PATIENT SAMPLE 7 WAS FROM A (B)(6) FEMALE. THE INITIAL RESULT WAS 84 (83.86) WITH A DATA FLAG AND THE REPEAT RESULT WAS 224. PATIENT SAMPLE 8 WAS FROM A (B)(6) MALE. THE INITIAL RESULT WAS 115 ( 114.9) WITH A DATA FLAG AND THE REPEAT RESULT WAS 314. PATIENT SAMPLE 9 WAS FROM A (B)(6) FEMALE. THE INITIAL RESULT WAS 325 (324.7) AND THE REPEAT RESULT WAS 521. PATIENT SAMPLE 10 WAS FROM A (B)(6) FEMALE. THE INITIAL RESULT WAS 301 (301.0) AND THE REPEAT RESULT WAS 514. PATIENT SAMPLE 11 WAS FROM A (B)(6) FEMALE. THE INITIAL RESULT WAS 446 (445.8) AND THE REPEAT RESULT WAS 693. PATIENT SAMPLE 12 WAS FROM A (B)(6) FEMALE. THE INITIAL RESULT WAS 252 (251.7) AND THE REPEAT RESULT WAS 425. PATIENT SAMPLE 13 WAS FROM A (B)(6) MALE. THE INITIAL RESULT WAS 326 (326.1) AND THE REPEAT RESULT WAS 518. PATIENT SAMPLE 14 WAS FROM A (B)(6) FEMALE. THE INITIAL RESULT WAS 249 (249.3) AND THE REPEAT RESULT WAS 428. PATIENT SAMPLE 15 WAS FROM A (B)(6) MALE. THE INITIAL RESULT WAS 353 (353.0) AND THE REPEAT RESULT WAS 549. PATIENT SAMPLE 16 WAS FROM A (B)(6) FEMALE. THE INITIAL RESULT WAS 62 (62.24) WITH A DATA FLAG AND THE REPEAT RESULT WAS 214. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE USER DID NOT KNOW IF THE PATIENTS WERE ADVERSELY AFFECTED, BUT ISSUED CORRECTED REPORTS. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS PINCHED TUBING COMING FROM THE PRESSURE SENSOR TO THE PROBE. HE PERFORMED PREVENTIVE MAINTENANCE AND RELOCATED THE PINCHED TUBING. TO VERIFY THE ANALYZER OPERATION, THE USER RAN CALIBRATION AND QUALITY CONTROL WHICH WERE SUCCESSFUL. PRECISION TESTING WAS ALSO PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAMIN B12 RADIOASSAY, VITAMIN B12 CDD ROCHE DIAGNOSTICS NA 16080707

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR