MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGLYCERIDES; TRIGLYCERIDES ASSAY

Catalog Number	08058687190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer performed reagent carryover check and precision check and both checks passed.A general reagent problem was ruled out because qc results were acceptable.The investigation determined the issue is consistent with incorrect pre-analytic sample handling.No product problem was found.
Event or Problem Description
We received an allegation of questionable results for 1 patient's sample tested with the trigl assay on cobas pro c 503 analytical unit serial number (b)(4).On (b)(6) 2023 at 8:27 a.M.The customer ran 1 patient's sample and initially resulted in trigl value of 266 mg/dl.The result was reported to the physician but it did not correlate with the patient's clinical picture so he asked to retest the sample again.On the same day at 10:45 a.M.The patient's sample was repeated from the same primary tube and on the same analyzer and resulted in trigl value of 143 mg/dl.Later in the day, the patient's sample was repeated but this time on another c503 module, and resulted in trigl value of 144 mg/dl.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16479853
• Report Number: 1823260-2023-00644
• Device Sequence Number: 16931615
• Product Code: CDT
• UDI-Device Identifier: 07613336121542
• UDI-Public: 07613336121542
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2023

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 Expiration Date: 12/31/2023
• Device Catalogue Number: 08058687190
• Device Lot Number: 67754101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 03/03/2023
• 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