MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGLYCERIDES; TRIGLYCERIDES ASSAY

Catalog Number 08058687190

Device Problem High Test Results (2457)

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

Event Date 01/12/2024

Event Type  malfunction  

Manufacturer Narrative

The c503 analyzer serial number was (b)(6).Calibration and qc were acceptable.An "abnormal aspiration" message was observed on the alarm trace data around the time of the event.The hardware performance check results showed issues with cell rinse functionality.The field service engineer (fse) cleaned the probes as there were some particles on the sodium hydroxide (naoh) probe.The suction probe was dripping; the vacuum line was bleached.The investigation is ongoing.

Event Description

The initial reporter complained of a discrepant high result for 1 patient sample tested for triglycerides (trigl) on a cobas c 503 analytical unit.The initial result was 5.27 g/l.The sample was repeated twice with results of 1.00 g/l.The questionable result was not reported outside of the laboratory.The repeat results were believed to be correct.

Manufacturer Narrative

Section d, device identification was updated.Relevant fields of sections d and g were updated.The trigl reagent lot number was 766131 with an expiration date of (b)(6)2024.The investigation determined the service actions resolved the issue.

• Brand Name: TRIGLYCERIDES
• Type of Device: TRIGLYCERIDES ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18641006
• MDR Text Key: 334555783
• Report Number: 1823260-2024-00321
• Device Sequence Number: 1
• Product Code: CDT
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K191899
• 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: 02/28/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08058687190
• Device Lot Number: 766131
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• 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
• Patient Age: 20 YR
• Patient Sex: Female