MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGLYCERIDES; TRIGLYCERIDES ASSAY

Catalog Number	08058687190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with triglycerides on a cobas c 503 analytical unit.No questionable results were reported outside of the laboratory.The first sample initially resulted in a triglycerides value of 7.37 g/l.The sample was repeated twice, resulting in values of 1.80 g/l and 1.81 g/l.The value of 1.81 g/dl was communicated to the clinician.The second sample initially resulted in a triglycerides value of 6.03 g/l.The sample was repeated twice, resulting in values of 1.82 g/l and 1.81 g/l.The value of 1.81 g/dl was communicated to the clinician.
Additional Manufacturer Narrative
The serial number of the c 503 analyzer is (b)(6).Calibration data was acceptable.Quality controls were within range on the day of the event.A review of the reaction data for the initial values showed the reaction kinetics did not reach a plateau, which means something in the mixture kept reacting leading to the high results.Upon review of the alarm trace, there were 85 abnormal aspiration alarms present.There were also a number of photometer check alarms.The investigation is ongoing.
Additional Manufacturer Narrative
A general reagent issue can be ruled out as calibration and controls are acceptable.Precision studies were performed and were outside of acceptable limits.The investigation did not identify a product issue.The issue is consistent with insufficient pre-analytic sample handling and insufficient maintenance.

• Brand Name: TRIGLYCERIDES
• Common Device Name: TRIGLYCERIDES 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: 19719599
• Report Number: 1823260-2024-01988
• Device Sequence Number: 12798786
• Product Code: CDT
• UDI-Device Identifier: 07613336121542
• UDI-Public: 07613336121542
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K951595
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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: 03/31/2025
• Device Catalogue Number: 08058687190
• Device Lot Number: 78840901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 07/25/2024
• 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