BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHYL ALCOHOL

    MDR report key: 2132642 · Received June 17, 2011

    Report

    Report Number
    1823260-2011-03319
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 13, 2011
    Report Date
    November 30, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DML
    PMA / PMN Number
    K952839
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER INVESTIGATION, THE SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. FURTHER INVESTIGATION WAS NOT POSSIBLE DUE TO MISSING INFORMATION. IT WAS SUSPECTED A DILUTION FACTOR FOR A PREVIOUS SAMPLE COULD HAVE COULD HAVE BEEN APPLIED TO THIS SAMPLE IF THE USER DID NOT CONFIRM THE REMOVAL OF THE DILUTION IN THE TEST SELECTION SCREEN. THE PATIENT DID NOT RECEIVE ANY TREATMENT AND DID NOT LOSE ANY TREATMENT DUE TO THE EVENT. THE TAKING OF BLOOD SAMPLES AND THE TESTING TO PROVE ABSTINENCE OF ALCOHOL SHOULD BE DONE ONLY BY WELL TRAINED PERSONNEL AND IN CASE OF POSITIVE TESTING THE SAMPLE SHOULD BE IMMEDIATELY RETESTED, ALL CONDITIONS - AS IN THIS CASE, A DILUTION FACTOR FOR A PREVIOUS (OTHER) SAMPLE COULD HAVE TAKEN OVER BY NOT VERIFYING THE "SAMPLE VOLUME/DILUTION" IN TEST SELECTION SCREEN - ARE TO BE CONTROLLED BEFORE THE POSITIVE TESTING IS REPORTED OUT OF LABORATORY.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THE SAMPLE IN QUESTION WAS TESTED BY GC-MS (GAS CHROMATOGRAPHY-MASS SPECTROSCOPY) AND THE RESULT WAS NEGATIVE FOR ETHANOL.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED PROVIDING UPDATED INFORMATION FOR THE FOLLOWING MEDWATCH FIELDS: DATE OF BIRTH WAS (B)(6) AND AGE AT TIME OF EVENT WAS (B)(6). SEX WAS MALE. RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES: THE ETHANOL RESULT FROM (B)(6) 2011 WAS <50 AND THE ETHANOL RESULT FROM (B)(6) 2011 WAS <50. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS- CIRRHOSIS. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES- VITAMIN K, SPIRONOLACTONE, CALCICHEW D3 FORTE AND CODEINE PHOSPHATE. DATE RECEIVED BY MANUFACTURER WAS (B)(6) 2011. THE PATIENT HAS NOW BEEN ACCEPTED ONTO THE LIVER TRANSPLANT LIST.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE ETHANOL RESULTS FOR ONE PATIENT SAMPLE FROM THE ANALYTICAL P MODULE SERIAL NUMBER (B)(4). THE RESULTS WERE -10 MG/L, -6 MG/L AND 148 MG/L. THE RESULT OF 148 MG/L WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2011, THE CUSTOMER RETESTED THE SAMPLE WITH MANUAL DILUTIONS. THE RESULTS WITH A 1:10 DILUTION WERE -1.6 MG/L AND -1.7 MG/L. THE RESULT WITH A 1:50 DILUTION WAS 0.6 MG/L. THE PATIENT CLAIMED TO HAVE NOT DRUNK ANY ALCOHOL AND WAS REMOVED FROM A LIVER TRANSPLANT LIST. THE USER BELIEVED THE RESULT OF 148 MG/L WAS GENERATED WHEN THE SAMPLE WAS INADVERTENTLY TESTED WITH A 1:50 DILUTION THAT HAD BEEN PROGRAMMED FOR A PREVIOUS SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHYL ALCOHOL NAD-NADH, SPECIFIC REAGENT FOR ALCOHOL ENZYME METHOD DML ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR SPIRONOLACTONE| CODEINE PHOSPHATE| VITAMIN K| CALCICHEW D3 FORTE