MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HDL-CHOLESTEROL GEN.4

Catalog Number 07528566190

Device Problem Non Reproducible Results (4029)

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

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the cobas 8000 cobas c 502 module is (b)(6).The investigation is ongoing.

Event Description

The initial reporter received a questionable hdlc4 hdl-cholesterol plus 4th generation (hdl) assay result from one patient sample tested on the cobas 8000 cobas c 502 module.The initial result was reported outside of the laboratory.The physician rejected the patient sample due to the abnormally high result prompting the rerun on another c 502 module.The initial result from the module was 131 mg/dl.The repeat result from the other module was 43 mg/dl.The repeat result was deemed correct.

Manufacturer Narrative

The field service engineer (fse) inspected the module and determined the event was consistent with a damaged rinse tubing (hole in two tubes) and the cuvette rinse water washing into other cuvettes during suction.He then replaced the damaged rinse tubing and adjusted both the cuvette rinse water and gear pump pressure.He performed a hardware-by-test check performance and precision check with acceptable results after service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: HDL-CHOLESTEROL GEN.4
• Type of Device: HDL
• 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: 19088897
• MDR Text Key: 340370554
• Report Number: 1823260-2024-01122
• Device Sequence Number: 1
• Product Code: LBS
• UDI-Device Identifier: 04015630942565
• UDI-Public: 04015630942565
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K162593
• 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: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07528566190
• Device Lot Number: 73374901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• 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: 43 YR
• Patient Sex: Female