TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
Received Jul 2, 2024 · Event occurred Jun 9, 2024
Report 1823260-2024-01926 · MDR key 19659477
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsCatalog number
08056668190
Lot number
76516801
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
A PREANALYTIC SAMPLE HANDLING ISSUE OR INCOMPLETE USER MAINTENANCE COULD HAVE CONTRIBUTED TO THE ISSUE. BASED ON THE AVAILABLE DATA AND OBSERVED FAILURE MODE, THERE WAS NO EVIDENCE OF AN INSTRUMENT OR REAGENT ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (B)(4). THE CUSTOMER'S QC WAS ACCEPTABLE. THE CUSTOMER'S CALIBRATION TRACE SHOWED MANY STD.E, >CUVET, AND SAMP.S ALARMS. IT WAS NOTED THAT A HIGH NUMBER OF ABNORMAL CELL BLANK ALARMS WERE OBSERVED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. PATIENT 1: THE INITIAL RESULT WAS 8.14% AND THE REPEATED RESULT WAS 5.35%. PATIENT 2: THE INITIAL RESULT WAS 7.43% AND THE REPEATED RESULT WAS 5.54%. THE SAMPLES WERE REPEATED DUE TO THE RESULTS NOT CORRELATING WITH THE PATIENTS' GLUCOSE RESULTS.