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); Insufficient Device Problem Information (3190); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number is 665197.The expiration date was requested but not provided.
Event or Problem Description
The initial reporter received a questionablea1c-2 tina-quant hemoglobin a1c gen.3 result from one patient sample tested on the cobas c513 analyzer.The initial result was not reported outside of the laboratory.The reporter noticed a positive bias on the analyzer when they compared the results of the patient sample.The patient stated that there were two samples from the patient - sample 1 and sample 2.The initial result of sample 1 from analyzer 2 was 6.3%.The repeat result of sample 1 from analyzer 1 was 6.9% the reporter performed troubleshooting and ran both samples on analyzer 1 and another analyzer (analyzer 3).The results of sample 1 and sample 2 from analyzer 1 were both 6.3%.The results of sample 1 and sample 2 from analyzer 3 were both 6.6%.The result from analyzer 2 was deemed correct.
Additional Manufacturer Narrative
Medwatch fields d1 to d3 updated.The investigation reviewed the calibration recovery.The calibration recovery was only provided for the hemoglobin (hb) portion of the assay and did not contain calibration recovery prior to the event.The investigation reviewed the qc recovery.Only the cumulative qc statistics information was provided.Individual qc results were not provided.The investigation reviewed the customer's handling of patient samples; no issues were noted.The investigation reviewed the alarm trace; no issues were noted.The field service engineer (fse) inspected the analyzer and found no cause for the issue.He noted that the analyzer was working within specification.He performed instrument checks with successful results.Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• 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 46250-0457
• MDR Report Key: 17655413
• Report Number: 1823260-2023-02830
• Device Sequence Number: 3390319
• Product Code: LCP
• UDI-Device Identifier: 04015630942787
• UDI-Public: 04015630942787
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023
• 2 Devices were Involved in the Event: 1 2

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: 02/29/2024
• Device Catalogue Number: 07559674190
• Device Lot Number: 66519701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 09/29/2023
• 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