MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACETAMINOPHEN GEN.2; ACETAMINOPHEN TEST

Catalog Number	06769942190
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	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c 501 (ul) v module serial number was (b)(6).The field service engineer visited the customer's site and found that the reagent pack required replacement.The customer replaced the reagent pack.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with acetaminophen gen.2 assay on a cobas 6000 c 501 (ul) v module.Initial result: 196.0 g/ml.The customer noticed a qc shift.After the calibration and qc were performed again, the sample was repeated.Repeat result: 278.2 g/ml.The repeat result was deemed to be correct.
Additional Manufacturer Narrative
The calibration from (b)(6) 2025, showed that standard 1 recovered lower and standard 2 recovered higher; the recalibration was acceptable.The qc was within the customer's established ranges.The alarm trace showed "bath water level sensor" alarms and a "cell rinse cleaner 1 volume warning" alarm.The field service engineer found that the cause was related to the reagent pack.The customer's action of replacing the reagent pack with a new pack resolved the issue.No further issues were reported after the service visit.

• Brand Name: ACETAMINOPHEN GEN.2
• Common Device Name: ACETAMINOPHEN TEST
• 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: 23758941
• Report Number: 1823260-2025-05017
• Device Sequence Number: 13299478
• Product Code: LDP
• UDI-Device Identifier: 04015630935031
• UDI-Public: 04015630935031
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: 07/31/2026
• Device Catalogue Number: 06769942190
• Device Lot Number: 85557201
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/03/2026
• 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