TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
Received Jan 10, 2023 · Event occurred Dec 20, 2022
Report 1823260-2023-00093 · MDR key 16129886
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsModel number
NACatalog number
08056668190
Lot number
ASKU
Product problems
- High Test Results
- High Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER REPLACED THE REAGENT PACK WHICH RESOLVED THE ISSUE. THE INVESTIGATION DETERMINED THE ISSUE WAS WITH THE SPECIFIC REAGENT PACK.
Additional Manufacturer Narrative
THE CUSTOMER SUSPECTED THE REAGENT WAS NOT IN A TEMPERATURE-CONTROLLED ENVIRONMENT DURING SHIPMENT AND DROPPED BELOW THE ALLOWABLE TEMPERATURE. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE HEMOGLOBIN A1C RESULTS FROM THE COBAS PRO C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE CUSTOMER ESTIMATED 500 PATIENT RESULTS HAD TO BE CORRECTED. ONE REPRESENTATIVE EXAMPLE WAS PROVIDED OF AN ORIGINAL RESULT OF 6.9% AND A REPEAT RESULT OF 5.2%. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELOVED CORRECTED. ONE SURGERY WAS CANCELED AND A MEDICATION NOT NEEDED WAS ORDERED BUT NOT USED.