MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGLYCERIDES; TRIGLYCERIDES ASSAY

Catalog Number 08058687190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable triglyceride results from the cobas pro c 503 analytical unit.Patient 1 initial result was 438 mg/dl and the repeat results were 133 mg/dl and 132 mg/dl.Patient 2 initial result was 465 mg/dl and the repeat results were 221 mg/dl and 224 mg/dl.On (b)(6) 2023 ini tial result was 469 mg/dl and the repeat result was 82.3 mg/dl.The questionable results were not reported outside of the laboratory.

Manufacturer Narrative

The cobas pro c 503 analytical unit serial number was (b)(6).The quality control results were acceptable.The field service engineer decontaminated the sample probe, cleaned the rinse station/wash station.He ran quality controls and precision testing which passed.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.A general reagent or analyzer problem was not present, because the qc results were within range.

• Brand Name: TRIGLYCERIDES
• Type of Device: 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: 18335305
• MDR Text Key: 331059316
• Report Number: 1823260-2023-04029
• Device Sequence Number: 1
• Product Code: CDT
• UDI-Device Identifier: 07613336121542
• UDI-Public: 07613336121542
• Combination Product (y/n): Y
• Reporter Country Code: TH
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08058687190
• Device Lot Number: 73558801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1