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

Catalog Number	07559674190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas c513 analyzer commercial system is (b)(6).The reporter stated that they had a problem in the refrigerator that led to the freezing of the reagent packs.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable a1c-2 tina-quant hemoglobin a1c gen.3 results from two patient samples tested on the cobas c513 analyzer commercial system.The initial results were not reported outside of the laboratory.The patient samples were rerun on a cobas c 502.Patient sample 1 the initial result from the analyzer was 7.40%.The repeat result from the c 502 was 6.53%.Patient sample 2 the initial result from the analyzer was 6.97%.The repeat result from the c 502 was 5.88%.The repeat results were deemed correct. .
Additional Manufacturer Narrative
The investigation determined that based on the information provided, the event was consistent with incorrect storage conditions of the reagent pack (the reagent pack was frozen due to the customer's refrigerator problem).In addition, the customer did not run qc on the affected qc pack to detect the issue and exclude it from further measurements.Product labeling states "the reagents cannot be frozen.If freezing of a cassette is suspected a control measurement with this cassette is recommended." 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
• MDR Report Key: 17929407
• Report Number: 1823260-2023-03282
• Device Sequence Number: 15071099
• 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): 11/10/2023

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 Catalogue Number: 07559674190
• Device Lot Number: 672510
• 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: 09/19/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 11/10/2023
• 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