GGT-2 ¿-GLUTAMYLTRANSFERASE VER.2 - STANDARDIZED AGAINST SZASZ
Received Mar 9, 2020 · Event occurred Feb 5, 2020
Report 1823260-2020-00661 · MDR key 9804867
Device
Generic name
Gamma-glutamyl Transpeptidase And Isoenzymes Test System
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05168775190
Lot number
44430201
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE COUNTRY OF ORIGIN IS (B)(6). PREVIOUS CALIBRATION AND QC TESTS HAD ACCEPTABLE RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE GGT-2 -GLUTAMYLTRANSFERASE VER.2 - STANDARDIZED AGAINST SZASZ RESULTS FROM THE COBAS 8000 C (701) MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 120 U/L. THE TEST WAS REPEATED WITH AN INVALID RESULT. THE SAMPLE WAS REPEATED AT ANOTHER LABORATORY ON A SIEMENS ANALYZER ON ALIQUOT WITH A RESULT OF 32 U/L. THE CUSTOMER HAS KEPT THE FROZEN SERUM AND ON (B)(6) 2020 THE SAMPLE WAS RERUN TWICE WITH INVALID RESULTS. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY.