BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GGT-2 ¿-GLUTAMYLTRANSFERASE VER.2 - STANDARDIZED AGAINST SZASZ

    MDR report key: 7827934 · Received August 29, 2018

    Report

    Report Number
    1823260-2018-02915
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    August 9, 2018
    Report Date
    October 8, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JQB
    UDI-DI
    04015630916511
    PMA / PMN Number
    K951595
    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

    THE CUSTOMER'S COBAS 8000 MODEL USED WAS A C701. THE PATIENT SAMPLE WAS RECEIVED FOR FURTHER INVESTIGATION. THE RESULTS FROM THE INVESTIGATION HAVE RESULTS INDICATIVE OF A MONOCLONAL GAMMOPATHY. CLARIFICATION WAS REQUESTED IF THIS INTERFERENCE COULD HAVE CAUSED THE DISCREPANT RESULTS OBSERVED BUT CLARIFICATION WAS NOT PROVIDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY COMPLAINED ABOUT QUESTIONABLE CREP2 CREATININE PLUS VER.2 TESTED ON BOTH A COBAS 6000 C (501) MODULE AND A COBAS 8000 (UNSPECIFIED MODULE) COMPARED TO AN ABBOTT SYSTEM. FROM THE DATA PROVIDED, A REPORTABLE MALFUNCTION WAS PROVIDED FOR CREP2, ASTLP ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION, ALTLP ALANINE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION, AND GGT-2 -GLUTAMYLTRANSFERASE VER.2 STANDARDIZED AGAINST IFCC / SZASZ. THIS MEDWATCH WILL COVER GGT-2. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION ON ASTLP. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION ON CREP2. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION ON ALTLP. THE ERRONEOUS RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY. THE PATIENT WAS SENT TO THE HOSPITAL DUE TO THE INITIAL HIGH CREP2 RESULT, BUT THERE WAS NO ALLEGATION THAT THE PATIENT WAS ADVERSELY AFFECTED. THE COBAS C501 SERIAL (B)(4). THE CUSTOMER DID NOT PROVIDE ANY SPECIFIC INFORMATION ON THE COBAS 8000 SYSTEM. A PRELIMINARY ASSESSMENT OF THE CASE STATED THAT BASED ON PREVIOUS ELECTROPHORESIS TESTING OF THE PATIENT, THE PATIENT IS BELIEVED TO HAVE AN INTERFERING FACTOR PRESENT. THE INVESTIGATION IS CURRENTLY ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666683 GGT-2 ¿-GLUTAMYLTRANSFERASE VER.2 - STANDARDIZED AGAINST SZASZ GAMMA-GLUTAMYL TRANSPEPTIDASE AND ISOENZYMES TEST SYSTEM JQB ROCHE DIAGNOSTICS NA ASKU 04015630916511

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR BACTRIM| INEXIUM| KARDEGIC| LEDERFOLINE| MILLEPERTUIS| PRETERAX| TAHOR| ZELITREX