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	02/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The calibration and qc recovery data provided was acceptable.The alarm trace showed two sample short alarms.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable nh3l ammonia results for 1 patient edta plasma sample on a cobas 6000 c501 module.The initial nh3l result was 11.9 umol/l.The doctor questioned the result which prompted the customer to repeat the sample.The sample was repeated and the repeat result was 42.9 umol/l with flag.
Additional Manufacturer Narrative
The investigation ruled out a general reagent problem because the calibration and qc were acceptable.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 18790747
• Report Number: 1823260-2024-00561
• Device Sequence Number: 8296484
• Product Code: JIF
• UDI-Device Identifier: 04015630936526
• UDI-Public: 04015630936526
• Combination Product (Y/N): Y
• Initial Reporter Country: SF
• 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): 03/22/2024

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: 734907
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 03/22/2024
• 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: 53 YR
• Patient Sex: Male