TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
Received Apr 5, 2023 · Event occurred Mar 2, 2023
Report 1823260-2023-01096 · MDR key 16681835
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsModel number
NACatalog number
08445699190
Lot number
ASKU
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Non Reproducible Results
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE CODE WAS UPDATED. THE INVESTIGATION DETERMINED THE CUSTOMER'S ACTIONS (REPLACING THE REAGENT PACK AND FORCING A NEW LOT CALIBRATION) RESOLVED THE ISSUE.
Description of Event or Problem
WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 1 PATIENT SAMPLE TESTED WITH A1CX3 ASSAY ON A COBAS PRO C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE FOLLOWING RESULTS WERE REPORTED: INITIAL RESULT: 10.8%, REPEATED RESULT: 9.5%. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEATED RESULT OF 9.5% DEEMED TO BE CORRECT.
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER FOUND THAT A1C QC WAS OUT OF RANGE. THE CUSTOMER REPLACED THE CALIBRATOR WITH A NEW LOT. QC WAS PERFORMED AND IT WAS WITHIN THE NORMAL RANGE.