MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGL; TRIGLYCERIDE TEST SYSTEM

Catalog Number 20767107322

Device Problem Low Test Results (2458)

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

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas 6000 c501 (ul) v module 1 is (b)(6).The serial number of the customer's cobas 6000 c501 (ul) v module 2 is (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable trigl triglycerides results from an estimated minimum of 50 patient samples tested on two cobas 6000 c501 (ul) v (module 1 and module 2).The reporter was able to provide one patient sample with discrepant results: the initial result was not reported outside of the laboratory.The reporter stated that the qc would not pass and there was a high number of patient sample results with an invalidating data flag or very low results, prompting the rerun of previous patient samples on their other c501 module.The reporter stated that they noticed the issue after service was performed on their deionized (di) water system.The initial result from module 1 was 153 mg/dl.The repeat result from module 2 was 212 mg/dl.The repeat result could not be determined as both analyzers were affected by the water source issue.

• Brand Name: TRIGL
• Type of Device: TRIGLYCERIDE TEST SYSTEM
• 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: 18977097
• MDR Text Key: 338613590
• Report Number: 1823260-2024-00898
• Device Sequence Number: 1
• Product Code: CDT
• UDI-Device Identifier: 04015630918393
• UDI-Public: 04015630918393
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K873049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20767107322
• Device Lot Number: 74902501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• 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