TINA-QUANT COMPLEMENT C3C TEST SYSTEM
Received Feb 22, 2024 · Event occurred Jan 20, 2024
Report 1823260-2024-00524 · MDR key 18760036
Device
Generic name
Complement C3 Test
Manufacturer
Roche DiagnosticsCatalog number
08105537190
Lot number
64986301
Product problems
- High Test Results
- Output Problem
- High Test Results
- Output Problem
Patient
13 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE C3C-2 TINA-QUANT COMPLEMENT C3C VER.2 AND C4-2 TINA-QUANT COMPLEMENT C4 VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO C 503 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER C3C. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE C4 RESULTS. ON (B)(6) 2024, THE INITIAL C3C RESULT WAS 62.6 MG/DL. THE DOCTOR QUESTIONED THE RESULTS AND THE SAMPLE WAS REPEATED. ON (B)(6) 2024, THE SAMPLE WAS REPEATED AND THE REPEAT C3C RESULT WAS 104 MG/DL.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE ALARM TRACE SHOWED 36 ABNORMAL ASPIRATION ALARMS. BLOOD WAS VISIBLE IN THE GEL LAYER OF THE SAMPLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH PRE-ANALYTICAL SAMPLE HANDLING ISSUES.