MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGL TRIGLYCERIDES; TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL

Model Number	TRIGL
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation for this event is ongoing.The follow up/corrective action for this event is not available.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction events.Non-reproducible results were generated by the cobas 8000 c 702 module for trigl triglycerides.The event involved a total of 1 patient.
Additional Manufacturer Narrative
The investigation determined the following: upon review of data for the initial and subsequent repeat results, the sample was determined to be very concentrated.Reaction kinetics show that an oxygen depletion happened and prozone flagging by the analyzer should have been triggered.In certain cases, a measuring point of the reaction may become an outlier due to neighboring cell mixing effects causing no prozone flags to be calculated.The investigation could not identify a product problem.

• Brand Name: TRIGL TRIGLYCERIDES
• Common Device Name: TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8549721
• Report Number: 1823260-2019-90128
• Device Sequence Number: 14068021
• Product Code: CDT
• UDI-Device Identifier: 04015630925117
• UDI-Public: 04015630925117
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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?: No
• Operator of Device: No Information
• Device Model Number: TRIGL
• Device Lot Number: 328103
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 07/22/2019
• Patient Sequence Number: 1