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

Catalog Number	07229593190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6000 c 501 serial number was (b)(6).The customer loaded a new reagent pack of a different lot (83242101) that was from a different shipment.The customer repeated previously tested proficiency samples and the results were much lower.For troubleshooting purposes, the customer also tested samples drawn from employees on both reagent packs and the results were much lower with the new reagent pack.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable high ammonia ii results from the cobas 6000 c 501 analyzer.The doctor questioned the high result as it did not match the clinical picture.The initial result was 383 mol/l.The customer repeated the same and the result was still high.No specific data was provided.The result from a new sample from the patient tested at another laboratory was <10 mol/l.This result was believed to be correct.
Additional Manufacturer Narrative
The field service engineer determined there was an issue with the ammonia reagent cassette.He replaced the gear pump as the gauge was not working, and replaced the rinse tubing.He ran precision testing.The investigation determined that the service actions resolved the issue.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21772756
• Report Number: 1823260-2025-01008
• Device Sequence Number: 10161417
• Product Code: JIF
• UDI-Device Identifier: 04015630936526
• UDI-Public: 04015630936526
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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: 11/30/2025
• Device Catalogue Number: 07229593190
• Device Lot Number: 81369501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/22/2025
• 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 Age: 7 YR
• Patient Sex: Male