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

Catalog Number 05171407190

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)# (b)(4). The event occurred in: (b)(6).

Event Description

The customer complained of a questionable result for 1 patient tested for trigl triglycerides (trigl) on a cobas 8000 c (701) module. The initial trigl result was 182 mg/dl. The same sample was retested with a 1:20 dilution with a result of 10683 mg/dl. The erroneous result was released outside of the laboratory. There was no allegation of an adverse event. The trigl reagent lot was 25141601 with an expiration date of 30-jun-2018. The investigation is currently ongoing.

Manufacturer Narrative

Further analysis of the low trigl result of 182 mg/dl reaction monitor showed a reaction that indicated an oxygen depletion during the reaction. This low result should have been flagged with a data flag, but it was discovered by the field engineering specialist that the customer was not using the most current version of the trigl test application. Once the customer deleted the old test application version and installed the correct application version, the sample was retested and was correctly flagged by the analyzer.

• Brand Name: TRIGL TRIGLYCERIDES
• Type of Device: TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7454646
• MDR Text Key: 107092526
• Report Number: 1823260-2018-01266
• Device Sequence Number: 1
• Product Code: CDT
• Combination Product (y/n): N
• PMA/PMN Number: K873049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 05171407190
• Device Lot Number: 25141601
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No