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

Model Number	TRIGL
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calibration data trace showed multiple failed calibrations flagged with a standard error from (b)(6) 2023.When the error occurs, the prior calibration remains in effect.The qc data recovery was acceptable on the day of the event.A reagent issue could be ruled out because calibration and controls were acceptable.The alarm trace showed multiple abnormal probe-sucking errors.The customer changed the cuvettes and ran qc successfully.Precision studies were performed for multiple parameters and precision was acceptable for all except triglycerides.The field service engineer cleaned the probes.Special washes were checked and all were found to be installed.Precision studies and controls run after the service actions were ok.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable trigl triglycerides results for 2 patient samples on a cobas 6000 c501 module.For patient 1, the initial trigl result was 508.9 mg/dl.The repeat result was 292.9 mg/dl.For patient 2, the initial trigl result was 581.2 mg/dl.The repeat result was 157.0 mg/dl.No questionable results were reported outside of the laboratory.The analyzer serial number is (b)(4).
Additional Manufacturer Narrative
The investigation did not identify a product problem.The investigation found that the root cause of the event was consistent with pre-analytical handling issues.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16645960
• Report Number: 1823260-2023-01013
• Device Sequence Number: 17484673
• Product Code: CDT
• UDI-Device Identifier: 04015630918393
• UDI-Public: 04015630918393
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K873049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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: 07/31/2023
• Device Model Number: TRIGL
• Device Catalogue Number: 20767107322
• Device Lot Number: 64844301
• 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: 03/03/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 04/28/2023
• 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