TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
Received Feb 16, 2024 · Event occurred Jan 23, 2024
Report 1823260-2024-00457 · MDR key 18720114
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsCatalog number
08056668190
Lot number
708820
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE COBAS C 303 ANALYZER IS (B)(6). THE SAMPLE TUBE APPEARED UNDER-FILLED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS PURE C 303 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 7.91 % AND IT REPEATED AS 5.44 %.
Additional Manufacturer Narrative
THE CUSTOMER CONFIRMED THAT THE 5.44 % VALUE WAS THE ONE THAT WAS EXPECTED FOR THE PATIENT. THE PROVIDED QUALITY CONTROL DATA SHOWED SOME RESULTS THAT WERE OUTSIDE OF RANGE. THE SAMPLE TUBE WAS UNDERFILLED. THE INVESTIGATION DETERMINED THAT A REAGENT ISSUE IS NOT LIKELY. THE FIELD SERVICE ENGINEER CHECKED AND ADJUSTED THE RINSING ASSEMBLY AND CLEANED A PROBE. A HARDWARE PERFORMANCE CHECK WAS ACCEPTABLE. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.