MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHOLESTEROL GEN.2; CHOLESTEROL, ENZYMATIC

Catalog Number	08057443190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with cholesterol gen.2 (chol2) assay on a cobas c503 analytical unit.Initial result: 0.423 mmol/l.The customer didn't believe the initial result and repeated the sample.No questionable result was reported outside the laboratory.1st repeat result: 4.78 mmol/l.Homogenization of the sample was performed before repeating it for the 2nd time.2nd repeat result: 4.80 mmol/l.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
The chol2 reagent expiration date was not provided.The c503 analytical unit serial number was (b)(6).The alarm trace from (b)(6) 2024 till (b)(6) 2025 showed 189 abnormal cell blank alarms and 103 abnormal aspiration alarms.The investigation is ongoing.
Additional Manufacturer Narrative
A general reagent issue can be excluded as no further issues were reported and a correct rerun was performed with the same reagent.The provided data was analyzed with no findings.The field service engineer confirmed that the instrument was performing within specifications and no further issues were observed for six months.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CHOLESTEROL GEN.2
• Common Device Name: CHOLESTEROL, ENZYMATIC
• 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: 21422102
• Report Number: 1823260-2025-00500
• Device Sequence Number: 7913785
• Product Code: CHH
• UDI-Device Identifier: 07613336121115
• UDI-Public: 07613336121115
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K031824
• 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): 07/23/2025

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 Catalogue Number: 08057443190
• Device Lot Number: ASKU
• 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: 07/15/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 07/23/2025
• 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