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

Catalog Number 05171407190

Device Problem High Test Results (2457)

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

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter stated that 4 samples collected from the same patient and tested with trigl triglycerides on a cobas 8000 c (701) module.The specific date the event occurred was requested, but not provided.The customer stated that triglyceride measurements of the 4 samples yielded high results of > 1000 mg/dl.The measurements were not considered plausible by the customer as they did not agree with other diagnostic findings of the patient.The results from three of the four samples were reported outside of the laboratory with a comment stating the results were not plausible.The serial number of the c 701 analyzer is 17j2-08.

Manufacturer Narrative

A sample from the patient was provided for investigation.The sample was analyzed with the roche trigl triglycerides reagent (trigl) and with a special laboratory batch of the triglycerides reagent (trigla) which does not contain any lipoprotein lipase and thus only records the content of free glycerol in the sample.The difference between the two measurements, trigl = 28.0 mmol/l and trigla = 26.2 mmol/l, results in a difference of 1.8 mmol/l triglycerides.This corresponds to the true level of triacylglycerides in the sample.The measured value of free glycerol in the sample, 26.2 mmol/l, confirms the finding of pseudo hypertriglyceridemia due to the lack of glycerol kinase activity in the patient sample.The investigation concludes the patient suffers from pseudo hypertriglyceridemia due to a lack of glycerol kinase.There is no interference through drugs.The issue is sample-specific.

• Brand Name: TRIGL
• 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: 13869625
• MDR Text Key: 297804309
• Report Number: 1823260-2022-00829
• Device Sequence Number: 1
• Product Code: CDT
• UDI-Device Identifier: 04015630925117
• UDI-Public: 04015630925117
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05171407190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• 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
• Treatment: CYCLOPHOSPHAMID; MYCOPHENOLAT