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

Catalog Number	07559674190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c513 analyzer serial number is (b)(6).The field service representative (fsr) checked calibration, qc, and operator maintenance and did not identify any issues.Instrument performance testing was acceptable.Frequent abnormal aspiration alarms were observed on the alarm trace data.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant high results for 2 patient samples tested for tina-quant hemoglobin a1cdx gen.3 on a cobas c513 analyzer.Patient 1 initial result was 7.41% on (b)(6) 2023 the sample was repeated on a cobas 8000 c 502 module with a result of 5.86%.Patient 2 initial result was 11.03%.On (b)(6) 2023 the sample was repeated on a cobas 8000 c 502 module with a result of 9.51%.
Additional Manufacturer Narrative
The field service engineer (fse) made reagent and sample probe adjustments.The cuvette segments were seated properly.The sample probe was checked for obstructions by flushing.The fse noted that the reagent packs may have frozen in the customer's refrigerator.The customer has not complained of any further issues.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 17766033
• Report Number: 1823260-2023-03008
• Device Sequence Number: 20487596
• Product Code: LCP
• UDI-Device Identifier: 04015630942787
• UDI-Public: 04015630942787
• Combination Product (Y/N): Y
• Initial Reporter Country: EG
• 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): 11/03/2023

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 Expiration Date: 01/31/2024
• Device Catalogue Number: 07559674190
• Device Lot Number: 67251001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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