BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-03682

    MDR report key: 4857149 · Received June 19, 2015

    Report

    Report Number
    1823260-2015-03682
    Event Type
    Malfunction
    Date Received
    June 19, 2015
    Date of Event
    May 21, 2015
    Report Date
    July 7, 2015
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE LIMITED DATA AVAILABLE, A CLEAR ROOT CAUSE COULD NOT BE IDENTIFIED. A POSSIBLE ROOT CAUSE MAY BE RELATED TO AN INSTRUMENT ISSUE AND/OR A PRE-ANALYTICAL ISSUE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 3 PATIENT SAMPLES TESTED FOR VITAMIN B12. THE ERRONEOUS RESULTS FOR PATIENT 1 WERE REPORTED OUTSIDE OF THE LABORATORY. IT IS NOT KNOWN IF THE ERRONEOUS RESULTS FOR PATIENTS 2 AND 3 WERE REPORTED OUTSIDE OF THE LABORATORY. PATIENT SAMPLE 1 INITIAL VITAMIN B12 RESULT WAS <30 PG/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS 32 PG/ML. THIS RESULT WAS REPORTED TO THE PHYSICIAN WHO DOUBTED THE RESULT AND REQUESTED THE SAMPLE BE TESTED IN ANOTHER LABORATORY. THE SAMPLE WAS REPEATED ON AN E170 ANALYZER AND THE RESULT WAS 152.4 PG/ML. PATIENT SAMPLE 2 ((B)(6) MALE) INITIAL VITAMIN B12 RESULT WAS <30 PG/ML. THE SAMPLE WAS SENT TO ANOTHER LABORATORY WHERE IT WAS REPEATED ON AN E170 ANALYZER AND THE RESULT WAS 217 PG/ML. PATIENT SAMPLE 3 (GENDER AND DOB IS NOT KNOWN) INITIAL VITAMIN B12 RESULT WAS 130 PG/ML. THE SAMPLE WAS SENT TO ANOTHER LABORATORY WHERE IT WAS REPEATED ON AN E170 ANALYZER AND THE RESULT WAS 325 PG/ML. NO ADVERSE EVENT OCCURRED. THE VITAMIN B12 REAGENT LOT WAS 183415 WITH AN EXPIRATION DATE OF 02/29/2016. CALIBRATION AND QUALITY CONTROLS WERE WITHIN SPECIFICATION. THE MEASURING CELL WAS LAST CHANGED ON (B)(6) 2013. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED.

    Patients

    Seq Age Sex Outcome Treatment
    1 026 YR PATIENT 1 - NO MEDICATION| PATIENT 3 - NOT PROVIDED| PATIENT 2 - NOT PROVIDED