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

Catalog Number	08057443190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c503 analyzer serial number was (b)(6).Calibration and qc were acceptable.Precision results were acceptable.
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for cholesterol gen.2 (chol2) on a cobas c 503 analytical unit.The initial result was 6.59 mg/dl.The repeat result was 201 mg/dl.
Additional Manufacturer Narrative
The reaction monitor data provided for the initial result showed very low absorbance, indicating that a low sample volume was pipetted.Many abnormal cell blank alarms occurred on the day of the event.It was noted that preventive maintenance actions were performed by the field service engineer (fse).The specific actions performed were not provided.The investigation determined the event was consistent with a single pipetting incident (low sample volume).A product issue was not found.

• 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: 23860438
• Report Number: 1823260-2025-05261
• Device Sequence Number: 21245209
• Product Code: CHH
• UDI-Device Identifier: 07613336121115
• UDI-Public: 07613336121115
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 02/13/2026

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 08057443190
• Device Lot Number: 869385
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/21/2025
• Supplement Report FDA Received Date: 02/13/2026
• 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 Sex: Unknown