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

Catalog Number	07236450190
Medical Device Problem Codes	Low Test Results (2458); Infusion or Flow Problem (2964); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ammonia ii reagent expiration date was not provided.The c702 module serial number was (b)(6).The qc was within the assigned ranges on the day of the event.The investigation is ongoing.
Event or Problem Description
We received an allegation about questionable low results for 1 patient sample tested with ammonia ii assay on a cobas 8000 c702 module.Initial result: 1361 ug/dl (tested with normal mode and accompanied by a data flag).The customer questioned the initial result as it was a very low negative result and repeated the sample using different dilution factors in a decrease mode: 1st repeat result: 1700 ug/dl (using a dilution factor 1:2).2nd repeat result: 300 ug/dl (using a dilution factor 1:50).The sample was then repeated on a different c702 module in another site and the 4th repeat result was -600 ug/dl.
Additional Manufacturer Narrative
After the initial test, the patient was tested daily for 1 week; a new sample was obtained each day.The results consistently showed ammonia ii results of approximately [-] 1000 ug/dl on various unspecified modules.Testing was performed at another hospital using a c702 module with similar results.The specific results were not provided.

• Brand Name: AMMONIA II
• Common Device Name: ENZYMATIC METHOD, AMMONIA
• 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: 23339359
• Report Number: 1823260-2025-04263
• Device Sequence Number: 9470605
• Product Code: JIF
• UDI-Device Identifier: 04015630936533
• UDI-Public: 04015630936533
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 05/01/2026

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: 07236450190
• Device Lot Number: 869428
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 12/13/2025; 04/08/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 12/30/2025; 05/01/2026
• 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: 1000ML 10% (DEXTROSE, ELECTROLYTES); 500ML 5% (DEXTROSE, ELECTROLYTES); ALPIT INJECTION 5MG (CIMETROPIUM BROMIDE); HEPARIN SODIUM INJECTION 300IU/3ML (HEPARIN); MIDAZOLAM INJECTION 3MG/3ML (MIDAZOLAM); RAMNOS POWDER 250MG/1G/PK (LACTOBACILLUS); TNA (FISH OIL MULTI-NOURISHMENT SOLUTION 367ML)
• Patient Age: 12 MO
• Patient Sex: Unknown