MAUDE Adverse Event Report: ROCHE DIAGNOSTICS NH3L2; ENZYMATIC METHOD, AMMONIA

Catalog Number	07236450190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is 17m5-10.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable nh3l ammonia results for 2 patient samples on a cobas 8000 c702 module compared to cicaliquid nh3 reagent.For sample 1, the cobas nh3l result was 397 ug/dl.The circaliquid result was 150 ug/dl.For sample 2, the cobas nh3l result was 341 ug/dl.The circaliquid result was 172 ug/dl.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: NH3L2
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17541018
• Report Number: 1823260-2023-02618
• Device Sequence Number: 7402808
• Product Code: JIF
• UDI-Device Identifier: 04015630936533
• UDI-Public: 04015630936533
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K972250
• 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): 10/12/2023

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 10/12/2023
• 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