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 08/22/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received an erroneous result for one patient sample tested for trigl triglycerides (trigl) on a cobas 8000 c 702 module (c702).The erroneous result was not reported outside of the laboratory.The sample initially resulted as 397 mg/dl.The sample was repeated on a second c702 analyzer, resulting as 1130 mg/dl accompanied by a data flag.The sample was repeated on the second c702 analyzer with a decreased sample volume, resulting as 3986 mg/dl.No adverse events were alleged to have occurred with the patient.According to product labeling, extremely lipemic samples can produce normal results.The customer was not using the most current version of the application parameters.In the most current test application version, the prozone check limit value was reduced in order to allow flagging of incorrect low triglyceride results of lipemic patient samples on the c702 analyzer.The customer has updated the application parameters to the most current version and have not experienced any further issues.

Manufacturer Narrative

The issue was resolved by updating the application parameters to the most current version.The issue was caused by user error, since the most recent application settings were not used.

• Brand Name: TRIGL TRIGLYCERIDES
• Type of Device: TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6854629
• MDR Text Key: 85756407
• Report Number: 1823260-2017-01940
• Device Sequence Number: 1
• Product Code: CDT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K873049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 05171407190
• Device Lot Number: 238467
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1