TG G2 ELECSYS COBAS E 100 V2
Received Dec 14, 2023 · Event occurred Nov 24, 2023
Report 1823260-2023-04010 · MDR key 18329762
Device
Generic name
Thyroglobulin Test System
Manufacturer
Roche DiagnosticsCatalog number
08906556190
Lot number
730630
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- Non Reproducible Results
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- Non Reproducible Results
Patient
47 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE PROVIDED DATA DOES NOT INDICATE A REAGENT ISSUE. THE CUSTOMER WAS NOT USING THE TUBE ADAPTORS, WHICH ARE MANDATORY FOR 13 MM TUBES ON E 411 INSTRUMENTS. THE CUSTOMER USED AN INCORRECT DILUENT UNIVERSAL MATERIAL. PER PRODUCT LABELING FOR THE ASSAY, ONLY DILUENT MULTIASSAY SHOULD BE USED FOR DILUTIONS.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE TG G2 ELECSYS RESULTS FROM THE COBAS E411 DISK ANALYZER. THE INITIAL RESULT WAS 496.6 NG/ML WITH A DATA FLAG AND THE REPEAT RESULTS WERE 0.196 NG/ML WITH A DATA FLAG AND >500 NG/ML WITH A DATA FLAG. WITH A MANUAL 1:10 DILUTION, THE RESULT WAS 70.20 NG/ML. AFTER MULTIPLICATION BY THE DILUTION FACTOR OF 10, A RESULT OF 702 NG/ML WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER ALLEGED THAT ACCORDING TO A PATHOLOGIST, THE RESULTS DID NOT MATCH THE PATIENT'S CONDITION.
Additional Manufacturer Narrative
THE COBAS E411 DISK SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.