MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGLYCERIDES; TRIGLYCERIDES ASSAY

Catalog Number 08058687190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

The customer performed reagent carryover check and precision check and both checks passed.A general reagent problem was ruled out because qc results were acceptable.The investigation determined the issue is consistent with incorrect pre-analytic sample handling.No product problem was found.

Event Description

We received an allegation of questionable results for 1 patient's sample tested with the trigl assay on cobas pro c 503 analytical unit serial number (b)(4).On (b)(6) 2023 at 8:27 a.M.The customer ran 1 patient's sample and initially resulted in trigl value of 266 mg/dl.The result was reported to the physician but it did not correlate with the patient's clinical picture so he asked to retest the sample again.On the same day at 10:45 a.M.The patient's sample was repeated from the same primary tube and on the same analyzer and resulted in trigl value of 143 mg/dl.Later in the day, the patient's sample was repeated but this time on another c503 module, and resulted in trigl value of 144 mg/dl.

• Brand Name: TRIGLYCERIDES
• Type of Device: TRIGLYCERIDES ASSAY
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16479853
• MDR Text Key: 310957010
• Report Number: 1823260-2023-00644
• Device Sequence Number: 1
• Product Code: CDT
• UDI-Device Identifier: 07613336121542
• UDI-Public: 07613336121542
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K951595
• 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
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 08058687190
• Device Lot Number: 67754101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• 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