TINA-QUANT HBALC GEN. 3
Received Dec 15, 2023 · Event occurred Dec 1, 2023
Report 1823260-2023-04030 · MDR key 18335304
Device
Generic name
Assay, Glycosylated Hemoglobin
Manufacturer
Roche DiagnosticsCatalog number
05336163190
Lot number
73699601
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 PROBES WERE CLEANED, SEALS WERE REPLACED, AND THE WASH STATION WAS CLEANED. THE PROBES WERE REPLACED. THE WATER RESERVOIR WAS LAST CLEANED IN JANUARY 2023. PER PRODUCT LABELING, THE WATER RESERVOIR CLEANING INTERVAL IS EVERY 3 MONTHS. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE INTEGRA 400 PLUS ANALYZER IS (B)(6). CALIBRATION DATA SHOWED HIGH AND UNACCEPTABLE DEVIATIONS. 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 HBALC GEN. 3 ON A COBAS INTEGRA 400 PLUS. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 7.01 %. THE SAMPLE WAS REPEATED AT ANOTHER HOSPITAL ON AN UNKNOWN DEVICE ON 04-DEC-2023 AND THE HBA1C VALUE WAS 5.7 %. THE SAMPLE WAS REPEATED ON THE CUSTOMER'S INTEGRA 400 PLUS ANALYZER ON 05-DEC-2023, RESULTING IN A VALUE OF 6.73 %.