MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION; ASSAY, GLYCOSYLATED HEMOGLOBIN

Catalog Number	05336163190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 cobas c 502 module serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable tina-quant hemoglobin a1c gen.3 - hemolysate and whole blood application result from the cobas 8000 cobas c 502 module.Patient 1's initial result was 14.6% on (b)(6) 2024, and the repeat result was 6.8%.Patient 2's initial result was 9.3% on (b)(6) 2025, and the repeat result was 5.6%.Patient 3's initial result was 7.6% on (b)(6) 2025, and the repeat result was 5.4%.Patient 3's questionable result was repeated because the doctor questioned the result.Patient 1 & 2 were repeated due to a delta check.
Additional Manufacturer Narrative
Qc recovery was out of range on the date of the event.A field service engineer (fse) determined that a specific root cause was not found and performed a decontamination, replaced all pipettor seals, vacuum valves, rinse mechanism tubing, detergent vacuum tubing, all cells, vacuum diaphragms, flapper valves, and the gear pump head.The fse verified all mechanisms were adjusted and working properly, all water and vacuum pressures, and completed calibration and qc for hba1c; all results were passing.The investigation was unable to determine a direct root cause; the instrument was verified, and the service actions appear to have resolved the issue.

• Brand Name: TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION
• Common Device Name: ASSAY, GLYCOSYLATED HEMOGLOBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21761791
• Report Number: 1823260-2025-00998
• Device Sequence Number: 12923633
• Product Code: LCP
• UDI-Device Identifier: 04015630926275
• UDI-Public: 04015630926275
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K102914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 05336163190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown