BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 3327197 · Received September 5, 2013

    Report

    Report Number
    1823260-2013-05470
    Event Type
    Malfunction
    Date Received
    September 5, 2013
    Date of Event
    August 15, 2013
    Report Date
    October 23, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NFV
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE AS THE SAMPLE WAS NOT AVAILABLE FOR FURTHER TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED FALSE POSITIVE BENZODIAZEPINE RESULTS FROM TWO ANALYTICAL P MODULE ANALYZERS FOR ONE URINE SAMPLE. THE INITIAL RESULT FROM ANALYTICAL P MODULE SERIAL NUMBER (B)(4) WAS 437 NG/ML AND WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2013 THE CONFIRMATORY TEST PERFORMED BY (B)(6) WAS RECEIVED AND THE RESULT WAS NEGATIVE. THE SAMPLE WAS REPEATED ON ANALYTICAL P MODULE SERIAL NUMBER (B)(4) AND THE RESULTS WERE 433 NG/ML FROM AN ALIQUOT AND 413 NG/ML FROM THE ORIGINAL CONTAINER. THE REPEAT RESULT BY GC-MS WAS BELIEVED TO BE THE CORRECT RESULT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE BENZODIAZEPINE REAGENT LOT NUMBER WAS 68217001 WITH AN EXPIRATION DATE OF 01/31/2015. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE CHECKED THE VACUUM AND GEAR PUMP PRESSURES, CHANGED THE GEAR PUMP HEAD, CHECKED THE RINSE MECHANISM WITH NO PROBLEMS AND VERIFIED THE RINSE VOLUMES WERE WITHIN SPECIFICATIONS. HE NOTED THE REAGENT PROBES WERE LAST CHANGED ONE YEAR AGO SO HE CHANGED THE R1 & R2 PROBES, LUBRICATED THE SAMPLE AND REAGENT MECHANISMS AND CHECKED THE PROBE ALIGNMENTS AND RINSING OF THE PROBES. TO VERIFY THE ANALYZER OPERATION, HE RAN PRECISION TESTING WITH RESULTS WITHIN GUIDELINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441862 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER NFV ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 AMITRYPTYLINE 2X PER DAY| TRAMADOL 2X PER DAY| FLEXEROL 3X PER DAY| LYRICA 4X PER DAY| SYMBALTA 2X PER DAY| NAPOROXEN 2X PER DAY| PROZAC 20 1X PER DAY