BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALP2 ALP IFCC GEN.2

    MDR report key: 11775792 · Received May 5, 2021

    Report

    Report Number
    1823260-2021-01351
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 13, 2021
    Report Date
    July 30, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CJE
    PMA / PMN Number
    K033185
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRECISION TESTING RESULTS WERE ACCEPTABLE AND NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE REACTION MONITOR DATA. THE EVENT IS CONSISTENT WITH A HIGH LEUKOCYTE CONCENTRATION OF THE SAMPLES LEADING TO AN ACCUMULATION OF CELLS CLOSE TO THE PLASMA SURFACE. BOTH SAMPLES HAD A HIGH WHITE CELL COUNT. NEITHER A GENERAL INSTRUMENT OR REAGENT ISSUE WERE IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 1

    THE CALIBRATION, QC, AND PRECISION DATA WERE ACCEPTABLE. THEREFORE, A GENERAL REAGENT OR HARDWARE ISSUE WAS UNLIKELY. THE INVESTIGATION IS ONGOING. THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI) # (B)(4).

    Description of Event or Problem · 1

    THERE WAS AN ALLEGATION OF QUESTIONABLE ALP2 ALKALINE PHOSPHATASE RESULTS FOR TWO PATIENTS FROM COBAS 8000 COBAS C 502 MODULE SERIAL NUMBER (B)(4) AND A COBAS C702 MODULE. THE SERIAL NUMBER OF THE COBAS C702 WAS NOT PROVIDED. PATIENT 1: THE INITIAL RESULT WAS 1075 UI/L. THE CUSTOMER REPEATED THE SAMPLE MANUALLY AND THE RESULTS WERE 424, 259, 243, AND 250 UI/L. THE REPEAT RESULTS FROM A COBAS C702 MODULE WERE 828 UI/L AND 280 UI/L. ON 14-APR-2021, A SECOND SAMPLE TUBE FROM THIS SAME PATIENT HAD RESULTS OF 370, 812 UI/L, AND 328 UI/L. ON 15-APR-2021, THE FIRST SAMPLE WAS REPEATED WITH RESULTS OF 213 WITH A DATA FLAG, 216 WITH A DATA FLAG, 217, 219, AND 234 UI/L. THE SECOND SAMPLE WAS REPEATED WITH RESULTS OF 235 WITH A DATA FLAG, 301 WITH A DATA FLAG, 385, 245, AND 280 UI/L. A NEW SAMPLE WAS COLLECTED AND THE RESULTS WERE 322, 298 WITH A DATA FLAG, 307 WITH A DATA FLAG, 825, 651 WITH A DATA FLAG, 609, AND 461 UI/L. PATIENT 2: ON 16-APR-2021, THE INITIAL RESULT FOR THE COBAS C502 WERE 301 UI/L AND 137 UI/L. AFTER DILUTION, THE RESULT WAS 99 UI/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671647 ALP2 ALP IFCC GEN.2 NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES CJE ROCHE DIAGNOSTICS NA 538640

    Patients

    Seq Age Sex Outcome Treatment
    1