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

Catalog Number	08057877190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas pure c 303 analytical unit is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable hdl- cholesterol gen.4 (hdlc4) assay results from two patient samples tested on the cobas pure c 303 analytical unit.Sample 1: the initial result was 218 mg/dl.The repeat result was 64 mg/dl.Sample 2: the initial result was 104 mg/dl.The repeat result was 42 mg/dl.The initial results were not reported outside the laboratory because they were deemed high and inconsistent with patients' histories.
Additional Manufacturer Narrative
The investigation did not identify a product problem based on the provided information.The cause of the event could not be determined.

• Brand Name: HDL-CHOLESTEROL GEN.4
• Common Device Name: HDL CHOLESTEROL 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: 21409818
• Report Number: 1823260-2025-00475
• Device Sequence Number: 21211924
• Product Code: LBS
• UDI-Device Identifier: 07613336121306
• UDI-Public: 07613336121306
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K162593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: 08057877190
• Device Lot Number: 76970301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 03/02/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown