MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ONLINE TDM ACETAMINOPHEN GEN. 2; COLORIMETRY, ACETAMINOPHEN

Catalog Number	08056684190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number was 799915.The expiration date was not provided.The field service engineer found there was a reagent pack in the outer wheel, causing an error.She placed the pack in the inner wheel and performed precision testing that passed.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable acetaminophen results for 11 patient samples from the cobas c 503 analytical unit.The initial results ranged from >200 to 12 ug/ml.The repeat results were all <5 ug/ml.A specific example was provided on an initial result of 50 ug/ml and a repeat result of <5 ug/ml.Some patients were treated with an anti-acetaminophen drug, but there were no adverse effects.
Additional Manufacturer Narrative
The field service engineer found the customer was using the incorrect calibrator material for the acetaminophen assay.It was confirmed that the customer's qc, which was performed after the calibration and before the patient sample testing using the incorrect material, had failed.The assay was recalibrated using the correct calibrator material, and the issue was resolved.Product labeling for the assay states to use the acet2 calibrator material.The investigation determined the event was due to the customer's error in using the incorrect calibration material.

• Brand Name: ONLINE TDM ACETAMINOPHEN GEN. 2
• Common Device Name: COLORIMETRY, ACETAMINOPHEN
• 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 46250-0457
• MDR Report Key: 22035908
• Report Number: 1823260-2025-01520
• Device Sequence Number: 13132566
• Product Code: LDP
• UDI-Device Identifier: 07613336120934
• UDI-Public: 07613336120934
• 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): 06/09/2025

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 08056684190
• Device Lot Number: 82111501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/09/2025
• 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