TINA-QUANT HEMOGLOBIN A1CDX GEN.3
Received Dec 15, 2025 · Event occurred Nov 24, 2025
Report 1823260-2025-05100 · MDR key 23801327
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsCatalog number
08056668190
Lot number
ASKU
Product problems
- Incorrect Measurement
- High Test Results
- Insufficient Device Problem Information
- Non Reproducible Results
- Incorrect Measurement
- High Test Results
- Insufficient Device Problem Information
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE HBA1C ASSAY ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF (B)(4). A NEW SAMPLE COLLECTED FROM THE PATIENT HAD AN HBA1C VALUE THAT TRIGGERED A LABORATORY DELTA CHECK ALERT BASED ON THE RESULT FROM THE COMPLAINED SAMPLE. DUE TO THIS, THE SAMPLE WAS REPEATED. THE COMPLAINED SAMPLE WAS REPEATED, RESULTING IN AN HBA1C VALUE OF (B)(4). THE REPEAT VALUE WAS DEEMED CORRECT.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE C 503 ANALYZER IS (B)(6). THE FIELD SERVICE ENGINEER WAS UNABLE TO DUPLICATE THE ISSUE. THE PROBE AND RINSE ADJUSTMENTS WERE CHECKED. THE CUSTOMER REPEATED THE PATIENT SAMPLE AND THE RESULTS WERE ACCEPTABLE. NO SPECIFIC DATA WAS PROVIDED. THE CUSTOMER RAN CALIBRATION AND CONTROLS. THE INVESTIGATION IS ONGOING.