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

Catalog Number	08056668190
Medical Device Problem Codes	Mechanical Problem (1384); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c503 analyzer serial number was (b)(6).The sample probe was replaced.The investigation is ongoing.
Event or Problem Description
We received an allegation of discrepant high results for 45 patient samples tested for tina-quant hemoglobin a1cdx gen.3 on a cobas c 503 analytical unit between (b)(6) 2024.The initial results were reported outside of the laboratory where the client complained.The repeat results were believed to be correct.Refer to the attached data for the patient results.Reagent lot 733771, expiration 31-oct-2024 was put on the analyzer on (b)(6) 2024.Reagent lot 765168, expiration 31-mar-2025 was put on the analyzer on (b)(6) 2024.Reagent lot 779801, expiration 30-apr-2025 was put on the analyzer on (b)(6) 2024.
Additional Manufacturer Narrative
Section d, device identification was updated.Relevant fields of sections d and g were updated.The field service engineer (fse) did not find a cause for the event.The fse cleaned the drippage from the covers and checked alignment and probe rinsing.Precision testing was acceptable.An instrument check was completed with no alarms.The instrument was operating within specification.Qc was acceptable.There is no indication of a reagent performance issue.There were multiple abnormal aspiration and sample short alarms noted on the date of the event near the time the samples were processed.The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
Section d, device identification was updated.Relevant fields of sections d and g were updated.The c503 analyzer serial number was (b)(6).A field service engineer (fse) did not find a cause for the event.The fse replaced the seals and nozzle tip.The sample probe was replaced and adjusted and all other adjustments were checked.The gear pump and main pump pressure were adjusted.The rinse levels were verified and customer maintenance was current.An instrument check and precision for a hardware check passed.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 46250-0457
• MDR Report Key: 19763723
• Report Number: 1823260-2024-02063
• Device Sequence Number: 21013822
• Product Code: LCP
• UDI-Device Identifier: 07613336120927
• UDI-Public: 07613336120927
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 10/04/2024

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: 08056668190
• Device Lot Number: 733771, 765168, 779801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 08/29/2024; 09/30/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/10/2024; 10/04/2024
• 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