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

Catalog Number	08057443190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 503 analyzer is (b)(4).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with cholesterol gen.2 on a cobas c 503 analytical unit.The sample initially resulted in a cholesterol value of 445 mg/dl and it repeated as 210 mg/dl.The sample was repeated 5 additional times on a second analyzer, resulting in the following values: 209 mg/dl, 211 mg/dl, 210 mg/dl, 209 mg/dl, 210 mg/dl, the sample was also repeated 5 additional times on the original analyzer, resulting in the following values: 211 mg/dl, 211 mg/dl, 211 mg/dl, 210 mg/dl, and 211 mg/dl.
Additional Manufacturer Narrative
Reaction data for the initial value showed an unusual reaction, with a sudden isolated increase in absorbance at a measuring point.Calibration and controls were acceptable.A general reagent problem can be ruled out.A review of alarm trace data showed abnormal aspiration and foam detection alarms on (b)(6) 2025.The field service engineer performed annual maintenance, including replacement of the gear pump kit and head.The engineer later returned and replaced the sample probe.Precision studies after the probe replacement were acceptable.Based on the provided information, the investigation determined the issue is consistent with insufficient pre-analytic sample handling.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23956775
• Report Number: 1823260-2026-00031
• Device Sequence Number: 20268627
• Product Code: CHH
• UDI-Device Identifier: 07613336121115
• UDI-Public: 07613336121115
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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): 02/26/2026

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/26/2026
• 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 Age: 65 YR
• Patient Sex: Male