MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGL; TRIGLYCERIDE TEST SYSTEM

Model Number	20767107322
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable trigl triglycerides results for 1 patient sample on a cobas 4000 c311 stand alone system.On (b)(6) 2023, the initial trigl result was 413 mg/dl.The customer questioned the high result and repeated the sample.On (b)(6) 2023, the first sample was repeated in a sample cup and the result was 97 mg/dl.On (b)(6) 2023, the original sample tube was repeated twice and the results were 104 mg/dl and 106 mg/dl.
Additional Manufacturer Narrative
It was found that the customer centrifuges patient samples for 10 minutes at 3000 g, which is too fast of a speed.The customer provided a picture of the patient sample which showed red strands in the gel barrier.Based on the available data, a general reagent issue could be excluded.The root cause of the event was found to be consistent with pre-analytical sample handling issues.
Additional Manufacturer Narrative
**udi related data quality updates only** d3 is the initial distributor in the us.

• Brand Name: TRIGL
• Common Device Name: TRIGLYCERIDE TEST SYSTEM
• 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: 17986362
• Report Number: 1823260-2023-03391
• Device Sequence Number: 20882799
• Product Code: CDT
• UDI-Device Identifier: 04015630918393
• UDI-Public: 04015630918393
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K873049
• 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,Followup
• Report Date (Section B): 08/29/2024

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: 02/29/2024
• Device Model Number: 20767107322
• Device Catalogue Number: 20767107322
• Device Lot Number: 71026301
• 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: 09/28/2023
• Supplement Date Received by Manufacturer: 11/06/2023; 08/29/2024
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 11/27/2023; 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown