TINA-QUANT HBALC GEN. 3
Received Jan 14, 2025 · Event occurred Dec 22, 2024
Report 1823260-2025-00132 · MDR key 21149025
Device
Generic name
Assay, Glycosylated Hemoglobin
Manufacturer
Roche DiagnosticsCatalog number
05336163190
Lot number
79405701
Product problems
- High Test Results
- Non Reproducible Results
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DUE TO THE LACK OF INFORMATION, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT HBALC GEN. 3 RESULT FROM THE COBAS INTEGRA 400 PLUS ANALYZER. THE INITIAL RESULT WAS 9.5%. THE PATIENT COMPLAINED ABOUT THE RESULT. THE SAME SAMPLE WAS REPEATED AND THE RESULT WAS 5.1%.
Additional Manufacturer Narrative
THE COBAS INTEGRA 400 PLUS SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.