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

Catalog Number	07229593190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 cobas c 502 module serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable ammonia ii results from the cobas 8000 cobas c 502 module.The initial result was 34.2 umol/l.The result from an abbott alinity i analyzer was 302.4 umol/l.The customer repeated the same sample on both analyzers.The repeat result from the cobas c502 was 54.4 umol/l.The repeat result from the abbott alinity i was 309.8 umol/l.The results from the abbott alinity i analyzer were believed to better fit the patient's clinical picture.
Additional Manufacturer Narrative
There was no evidence to suggest a malfunction of the device, as the values on the cobas c 502 were reproducible.The investigation determined the issue was consistent with to pre-analytical handling issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.

• 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: 21617667
• Report Number: 1823260-2025-00749
• Device Sequence Number: 20959830
• Product Code: JIF
• UDI-Device Identifier: 04015630936526
• UDI-Public: 04015630936526
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 07/24/2025

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: 01/31/2026
• Device Catalogue Number: 07229593190
• Device Lot Number: 83242101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 07/24/2025
• 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