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

Catalog Number 20767107322

Device Problems Incorrect Measurement (1383); High Test Results (2457)

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

Event Date 09/20/2023

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The investigation is ongoing.

Event 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.

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.

• Brand Name: TRIGL
• Type of Device: 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
• MDR Text Key: 326364474
• Report Number: 1823260-2023-03391
• Device Sequence Number: 1
• Product Code: CDT
• UDI-Device Identifier: 04015630918393
• UDI-Public: 04015630918393
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: K873049
• 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: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 20767107322
• Device Lot Number: 71026301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2023
• 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