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	03/03/2025
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 a questionable tina-quant hemoglobin a1c gen.3 - hemolysate and whole blood application result from the cobas 8000 cobas c 502 module.The initial result was 9.0%, and the repeat result was 5.5%.The questionable result was repeated because the customer noticed that it did not match the patient's previous result.The repeat result was deemed to be correct.
Additional Manufacturer Narrative
In the alarm trace, there was an alarm that the water reservoir level was too low and an alarm for the incubation bath water level sensor.Qc and calibration were passing.A field service engineer (fse) determined that the gear pump pressure was slightly low.The fse decontaminated the entire analyzer, replaced all pipettor seals, vacuum valves, the rinse mechanism tubing, detergent vacuum tubing, all cells, vacuum diaphragms, flapper valves, and the gear pump head.He verified that all mechanisms were adjusted and working properly, verified all water and vacuum pressures, and ran calibration and qc that passed.The investigation was unable to determine a direct root cause.The customer has not reported any additional issues after the service was performed.

• 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: 21696832
• Report Number: 1823260-2025-00882
• Device Sequence Number: 8668338
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 03/26/2025
• 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