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

Catalog Number	08056684190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable online tdm acetaminophen gen.2 results for 1 patient sample on a cobas c 303 analytical unit.The initial result was 48.5 ug/ml.The nurse questioned the result, which prompted the customer to repeat the sample.The sample was repeated twice on another module, and both repeat results were <5 ug/ml with a flag.The repeat results were deemed correct.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The customer performed qc after the event and received a high concentration error.The field service engineer (fse) replaced the reagent pack and performed basic checks of the analyzer.The fse observed that the customer's reagent storage temperature is lower than the specifications.Calibration, qc, a precision test, and hardware checks were performed successfully.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration recovery data provided showed a history of failed calibrations.It was found that the customer's centrifugation time and spin speed is shorter and faster than recommended.The alarm trace did not contain a conspicuous event.The root cause of the event was found to be consistent with pre-analytical sample handling issues.No product problem was identified.

• 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
• MDR Report Key: 23744963
• Report Number: 1823260-2025-04993
• Device Sequence Number: 8835487
• Product Code: LDP
• UDI-Device Identifier: 07613336120934
• UDI-Public: 07613336120934
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/30/2026

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: 08056684190
• Device Lot Number: 85557601
• 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: 11/16/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/30/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLARITON.; MAALOX.; PROZAC.; VISTARIL.
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 60 KG