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

Catalog Number 05171407190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas 8000 cobas c 701 module is 19p8-02.The serum patient sample is suspected to have a high concentration of ascorbic acid.The patient sample was requested for investigation.The investigation is ongoing.

Event Description

The initial reporter received questionable trigl triglycerides and chol2 cholesterol gen.2 results from one patient sample tested on the cobas 8000 cobas c 701 module.This mdr is for the trigl assay.Please refer to mdr with a1.Patient identifier (b)(6) for the chol2 assay.The reported complained that the patient sample had chol2 and trigl results close to zero but the hdl-c and ldl-c totaled to over 100 mg/dl (hdl = 52 mg/dl; ldl = 53 mg/dl).The physician did not believe the results because they could not be correct and were incompatible with life.The reporter stated that there is an interference due to the therapy of paracetamol intoxication indicated in the four assays mentioned and also another interference for the chol2 and trigl assays.On (b)(6) 2024: the initial trigl result was <5 mg/dl.The first repeat result was <5 mg/dl.On (b)(6) 2024: the second repeat result was <5 mg/dl.

Manufacturer Narrative

The patient sample was received for investigation.The investigation sent the patient sample to another laboratory and was tested for triglycerides and cholesterol using a competitor assay and analyzer.The results are: triglycerides - 74 mg/dl.Cholesterol - 13 mg/dl.The investigation determined that the triglycerides assay from the competitor analyzer contains ascorbic acid oxidase; the result is acceptable and probably correct.The investigation determined that the cholesterol assay from the competitor analyzer does not contain ascorbic acid oxidase; the assay's cholesterol result is probably falsely low and is comparable to roche's cholesterol results.The investigation determined that the event was caused by an interferent (patient sample suspected to have a high concentration of ascorbic acid).Trigl product labeling states "exception: ascorbic acid and calcium dobesilate cause artificially low triglyceride results.Intralipid is directly measured as analyte in this assay and leads to high triglyceride results.The investigation did not identify a product problem.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18776406
• MDR Text Key: 336187063
• Report Number: 1823260-2024-00537
• Device Sequence Number: 1
• Product Code: CDT
• Combination Product (y/n): Y
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• 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: 03/26/2024
• 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: ALLOPURINOL 300; AMIODARON 200; ATORVASTATIN 40; CLOPIDOGREL 75; EPLERENON; ISOPROLOL 5; ISOTRETINOIN 5; KALINOR RETARD; L-THYROXIN 75; PANTOZOL B. BED.; TILIDIN 50/4; TORASEMID 20