BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NH3L AMMONIA

    MDR report key: 9920225 · Received April 3, 2020

    Report

    Report Number
    1823260-2020-00931
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Date of Event
    March 5, 2020
    Report Date
    August 27, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIF
    PMA / PMN Number
    K972250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S CALIBRATION AND QC WERE ACCEPTABLE BEFORE PATIENT TESTING. BASED ON THE CUSTOMER'S PRECISION TEST RESULTS, THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THE SAMPLE PIPETTING AND THE CUVETTE MIXING WAS NOT OPTIMAL. THE FSE PERFORMED PREVENTATIVE MAINTENANCE ON THE ANALYZER. BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE NH3L GEN.2 RESULTS FOR SEVEN PATIENTS FROM A COBAS 8000 C 702 MODULE, SERIAL NUMBER (B)(4). THE INITIAL AMMONIA RESULTS FOR PATIENT¿S 1-5 WERE REPORTED OUTSIDE THE LABORATORY, AND THE INITIAL RESULTS FOR PATIENT¿S 6-7 WERE NOT REPORTED OUTSIDE THE LABORATORY. REFER TO THE ATTACHMENT ON THE MEDWATCH FOR ALL INITIAL AND REPEAT AMMONIA RESULTS FOR PATIENT¿S 1-7. ON (B)(6) 2020, THE CUSTOMER RECOVERED HIGH AMMONIA RESULTS ON PATIENT 5¿S INITIAL AND REDRAWN SAMPLE. PATIENT 5 WAS TRANSFERRED TO ANOTHER FACILITY AND THE PATIENT WAS RETESTED USING AN UNKNOWN METHOD. THE AMMONIA RESULT FROM THE OTHER FACILITY WAS WITHIN NORMAL RANGE, 11 UMOL/L. ON (B)(6) 2020, THE CUSTOMER PERFORMED REPEAT TESTING ON PATIENT 5¿S SAMPLES AS WELL AS QUALITY CONTROL. PATIENT 5¿S AMMONIA RESULTS MATCHED THE PREVIOUS RESULTS AND QUALITY CONTROL WAS ACCEPTABLE. THE CUSTOMER NOTICED THAT ALL PATIENT AMMONIA RESULTS FROM (B)(6) 2020 RECOVERED HIGH. THE CUSTOMER PERFORMED REPEAT TESTING ON THESE SAMPLES, BUT THE RESULTS RECOVERED HIGHER DUE TO THE SAMPLE STABILITY. NEXT, THE CUSTOMER PERFORMED REPEAT TESTING ON FOUR PROFICIENCY SAMPLES RECEIVED IN (B)(6) 2019 AND (B)(6) 2020. THE PROFICIENCY SAMPLE RESULTS WERE REPRODUCIBLE AND WERE WITHIN THE TARGET RANGE. TWO NEW PATIENT SPECIMENS, PATIENT 6 AND PATIENT 7, ARRIVED WITHIN THE CUSTOMER¿S LABORATORY AND THE INITIAL AMMONIA RESULTS WERE HIGH. THE CUSTOMER PLACED A NEW AMMONIA REAGENT ONBOARD THE ANALYZER, LOT 416289 SERIAL NUMBER (B)(4), AND QUALITY CONTROL WAS ACCEPTABLE. THE CUSTOMER RETESTED PATIENT 6¿S SPECIMEN ON THE NEW REAGENT PACK AND THE AMMONIA RECOVERED WITHIN NORMAL RANGE. THE CUSTOMER RETESTED PATIENT'S 1-7 WITH THE NEW REAGENT PACK AND THE AMMONIA RESULTS RECOVERED LOWER. THE CUSTOMER DETERMINED THE AMMONIA RESULTS FROM THE NEW REAGENT PACK TO BE CORRECT. THE CUSTOMER REPORTED THESE RESULTS OUTSIDE THE LABORATORY. PATIENT 2 IS A (B)(6) FEMALE WITH A DATE OF BIRTH OF (B)(6). PATIENT 3 IS A (B)(6) MALE WITH A DATE OF BIRTH OF (B)(6). PATIENT 4 IS A (B)(6) FEMALE WITH A DATE OF BIRTH OF (B)(6). PATIENT 5 IS AN (B)(6) MALE WITH A DATE OF BIRTH OF (B)(6). PATIENT 6 IS A (B)(6) MALE WITH A DATE OF BIRTH OF (B)(6). PATIENT 7 IS A (B)(6) MALE WITH A DATE OF BIRTH OF (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386581 NH3L AMMONIA ENZYMATIC METHOD, AMMONIA JIF ROCHE DIAGNOSTICS NA 41628901

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR