MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT HEMOGLOBIN A1CDX GEN. 3; GLYCOSYLATED HEMOGLOBIN ASSAY

Catalog Number	08445699190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c303 analyzer serial number was (b)(6).The investigation found no issues with the current calibration.The investigation reviewed the alarm trace.There were several "abnormal aspiration" errors for the sample probe.The investigation reviewed the qc data; there were out-of-range (low) qc results for both levels; there were no out-of-range results since (b)(6) 2024.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter complained of questionable a1cx3 (hba1c) results not corresponding to the clinical picture for ten patient samples tested on the cobas pure c 303 analytical unit.The reporter complained that healthy patients had borderline to normal or too high hba1c results.The healthy patients reportedly had results of 5.8% to 6.4%.No repeat or additional results were provided.The customer declined to provide any additional event details.
Additional Manufacturer Narrative
H6 investigation findings and h6 investigation conclusion codes updated.

• Brand Name: TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
• Common Device Name: GLYCOSYLATED HEMOGLOBIN ASSAY
• 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: 19176354
• Report Number: 1823260-2024-01267
• Device Sequence Number: 3798250
• Product Code: LCP
• UDI-Device Identifier: 07613336157824
• UDI-Public: 07613336157824
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K072714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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: 08445699190
• Device Lot Number: 744199
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/06/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 06/10/2024
• 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