MAUDE Adverse Event Report: ROCHE DIAGNOSTICS AMMONIA II; ENZYMATIC AMMONIA METHOD

Catalog Number	07229593190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6000 c501 module serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
Roche diagnostics received a customer complaint regarding alleged low nh3l2 (ammonia) assay results for one patient sample tested on a cobas 6000 c501 module.The customer stated they loaded a new reagent cassette before the holidays but did not perform an initial calibration.The customer performed a calibration on (b)(6) 2026, and the calibration passed.No units of measure were provided for the ammonia assay.The patient sample initially recovered an ammonia value of -76 with a data flag.The test was re-calibrated and the sample was repeated, resulting in values of 26.3 and 26.8.The low values did not agree with the patient's clinical history and status.The patient was typically pathological, with values that were 120 to 130.Upon further calibration and repetition, the sample result was negative again, accompanied by a data flag.No specific data was provided.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The customer initially did not perform the mandatory calibration when the new reagent was loaded.The customer performed a successful recalibration.The customer did not run qc at the time of the event.Qc was only performed later with a new reagent cassette and was reported as successful.It was confirmed that the customer resolved the issue by replacing the reagent cassette.The investigation was unable to determine a direct root cause based on the provided information.The investigation did not identify a product problem.

• Brand Name: AMMONIA II
• Common Device Name: ENZYMATIC AMMONIA METHOD
• 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: 24148769
• Report Number: 1823260-2026-00245
• Device Sequence Number: 15755711
• Product Code: JIF
• UDI-Device Identifier: 04015630936526
• UDI-Public: 04015630936526
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K183517
• 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): 04/13/2026

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 Catalogue Number: 07229593190
• Device Lot Number: 869546
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 04/13/2026
• 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