MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P 501 POST-ANALYTICAL UNIT; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number	05158494001
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter establishment name: (b)(6).The cobas e 801 analytical unit's serial number is (b)(6).The reagent's lot number is 827232 with an expiration date of 30-apr-2026.The calibration and qc were acceptable.The provided images showed strong abnormalities in the sample (a bubble).The investigation determined the root cause of the issue was due to a bubble in the sample.Allegedly, the bubble was not present at the beginning of the sample workflow, and it appeared when the sample tube was handled by the cobas p501 (post-analytical system).It is not possible to determine how the bubble was formed in the sample.A bubble in the sample, caused by the cobas p501, could not be excluded.
Event or Problem Description
There was an allegation of questionable elecsys troponin t hs results for 1 patient sample on a cobas e 801 analytical unit.The initial result was 11.82 pg/ml.The repeated result was 356 pg/ml.This result was considered to be correct.The sample was recentrifuged and retested.The result was 357 pg/ml.The sample was repeated because the initial result didn't match the patient's clinical history.

• Brand Name: COBAS P 501 POST-ANALYTICAL UNIT
• Common Device Name: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• 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: 22576837
• Report Number: 1823260-2025-02243
• Device Sequence Number: 9681494
• Product Code: JQP
• UDI-Device Identifier: 04015630929061
• UDI-Public: 04015630929061
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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
• 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: 05158494001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2025
• Initial 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