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

Catalog Number	08056668190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable tina-quant hemoglobin a1cdx gen.3 results from six patient samples tested on the cobas pro c 503 analytical unit.The reporter was able to provide one patient sample with discrepant results: the initial result was reported outside of the laboratory.The physician questioned the result prompting the rerun of the patient sample.The initial result was 7%.The repeat result was 6%.The repeat result was deemed correct. .
Additional Manufacturer Narrative
The serial number of the customer's cobas pro c 503 analytical unit is (b)(6).The customer stated that the issue has been resolved with new calibrations of a new reagent lot.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation determined the customer's action (reagent replacement of new lot and calibration) resolved the issue.

• 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: 18854834
• Report Number: 1823260-2024-00686
• Device Sequence Number: 3338506
• Product Code: LCP
• UDI-Device Identifier: 07613336120927
• UDI-Public: 07613336120927
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 04/12/2024

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 Expiration Date: 08/31/2024
• Device Catalogue Number: 08056668190
• Device Lot Number: 71506001
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/12/2024
• 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