BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 801 ANALYTICAL UNIT

    MDR report key: 16707671 · Received April 10, 2023

    Report

    Report Number
    1823260-2023-01172
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 13, 2023
    Report Date
    June 2, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    07613336158456
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE PINCH VALVES AND PINCH TUBING. INSTRUMENT PERFORMANCE TESTING PASSED. THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    AN ABNORMAL LOW SIGNAL ALARM WAS OBSERVED ON THE DATE OF EVENT. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 8 PATIENTS TESTED WITH VITAMIN B12 (B12) AND FOLATE (FOL) ASSAYS ON COBAS E 801 ANALYTICAL UNIT. THE FOLLOWING RESULTS WERE PROVIDED: SAMPLE 1 (PATIENT 1): B12- 1ST RESULT: 1011 PMOL/L, 2ND RESULT: 313 PMOL/L, 3RD RESULT: 337 PMOL/L. SAMPLE 2 (PATIENT 2): B12- 1ST RESULT: 291 PMOL/L, 2ND RESULT: 100 PMOL/L, 3RD RESULT: 129 PMOL/L. SAMPLE 4 (PATIENT 3): FOL- 1ST RESULT: 3.7 NG/ML, 2ND RESULT: 6.12 NG/ML, 3RD RESULT: 4.0 NG/ML . SAMPLE 5 (PATIENT 4): B12- 1ST RESULT: 583 PMOL/L, 2ND RESULT: 363 PMOL/L, 3RD RESULT: 367 PMOL/L . SAMPLE 6 (PATIENT 5): B12- 1ST RESULT: 424 PMOL/L, 2ND RESULT: 314 PMOL/L, 3RD RESULT: 412 PMOL/L, 4TH RESULT: 415 PMOL/L, 5TH RESULT: 412 PMOL/L. FOL- 1ST RESULT: 3.43 NG/ML, 2ND RESULT: 5.6 NG/ML, 3RD RESULT: 5.59 NG/ML. SAMPLE 7 (PATIENT 6): B12- 1ST RESULT < SIGNAL, 2ND RESULT: 177 PMOL/L. SAMPLE 8 (PATIENT 7): B12- 1ST RESULT: 497 PMOL/L, 2ND RESULT: 389 PMOL/L, 3RD RESULT: 382 PMOL/L. SAMPLE 9 (PATIENT 8): B12- 2ND RESULT: 660 PMOL/L , 3RD RESULT: 250 PMOL/L, 4TH RESULT: 240 PMOL/L, 5TH RESULT: 241 PMOL/L. FOL- 1ST RESULT: 14.7 NG/ML, 2ND RESULT: 9.25 NG/ML, 3RD RESULT: 9.07 NG/ML. THE B12 REAGENT LOT NUMBERS WERE 66507300 AND 69549400. THE EXPIRATION DATE WAS NOT PROVIDED. THE FOL REAGENT LOT NUMBER 65768400. THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1794591 COBAS E 801 ANALYTICAL UNIT IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801 NA 07613336158456

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown