TINA-QUANT IGM GEN.2
Received Mar 3, 2025 · Event occurred Feb 7, 2025
Report 1823260-2025-00598 · MDR key 21503249
Device
Generic name
Igm (mu Chain Specific) Test
Manufacturer
Roche DiagnosticsCatalog number
08057923190
Lot number
82980401
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER CHECKED THE ANALYZER AND PERFORMED PRECISION TESTING THAT PASSED WITHIN THE GUIDELINES. THE CUSTOMER PERFORMED MAINTENANCE, DAILY STARTUP, AND QC WITHOUT ERROR AND WITH RESULTS WITHIN THE SPECIFIED RANGES. AS QC RECOVERY WAS WITHIN THE ACCEPTABLE RANGE, THERE WAS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT OR INSTRUMENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT IGM GEN.2 RESULTS FOR QC MATERIAL AND PATIENT SAMPLES FROM THE COBAS C 503 ANALYTICAL UNIT. ONE EXAMPLE WAS PROVIDED OF AN INITIAL RESULT OF 29 MG/DL AND A REPEAT RESULT OF 14.4 MG/DL. THE REPEAT RESULT WAS OBTAINED AFTER RECALIBRATING THE ASSAY.