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 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas pro c 503 analytical unit is (b)(6).The investigation is ongoing.

Event Description

The initial reporter received a questionable trigl triglycerides result from one patient sample tested on the cobas pro c 503 analytical unit.The initial result was 271 mg/dl.The repeat result was 129 mg/dl.

Manufacturer Narrative

The field applications specialist (fas) reviewed the event and determined the event was due to a preanalytic issue at the customer site.The fas inspected 30 random patient sample tubes and noted that 12 patient sample tubes had fibrin and gel when the tubes were inverted.The investigation did not identify a product problem.

• 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: 18291384
• MDR Text Key: 330049008
• Report Number: 1823260-2023-03904
• Device Sequence Number: 1
• Product Code: CDT
• Combination Product (y/n): Y
• Reporter Country Code: PE
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1