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 10/21/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that they received an erroneous results for one severely lipemic patient sample tested for trigl triglycerides (trig) on a cobas 8000 c 702 module (c702).The erroneous result was not reported outside of the laboratory.The sample initially resulted as 173.3 mg/dl.The sample was automatically diluted 1:50 and repeated on a different analyzer, resulting as 6863.7 mg/dl.No adverse events were alleged to have occurred with the patient.The c702 analyzer serial number was asked for, but not provided.The reaction monitor of the first result showed a strong decrease in absorbance due to oxygen depletion during the assay reaction.It was confirmed that 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.Upon review of calibration data, the last valid 2 point calibration was performed on (b)(6) 2017.From (b)(6) 2017 to (b)(6) 2017, successful blank calibrations were performed.Data was provided for one level of quality control and this was within range on the day of the event.Upon review of the alarm trace, several abnormal aspiration and sample short alarms could be observed from (b)(6) 2017 to (b)(6) 2017.The root cause is most likely related to the test application not being updated to the most current version.Based on the alarms received, a pre-analytic sample handling issue may also be a possible root cause.

• 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: 7009778
• MDR Text Key: 92609314
• Report Number: 1823260-2017-02557
• Device Sequence Number: 1
• Product Code: CDT
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• 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: 23846701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• 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