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

Catalog Number	05171407190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1823260-2022-00829
• Device Sequence Number: 4692575
• Product Code: CDT
• UDI-Device Identifier: 04015630925117
• UDI-Public: 04015630925117
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K873049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 05171407190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CYCLOPHOSPHAMID; MYCOPHENOLAT
• Patient Sex: Unknown