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

Catalog Number	07236450190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The customer suspects an interfering factor in the patient's sample.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable nh3l ammonia results for 1 patient sample on a cobas 8000 c702 module.The initial nh3 result was 135.1 umol/l.The customer was prompted to repeat the sample as there are internal protocols to rerun all samples that have a nh3 result of >100 umol/l.The sample was repeated twice and the results were 338.6 umol/l and 436.8 umol/l.
Additional Manufacturer Narrative
The investigation found that the patient was taking erwinase.Per erwinase labeling, the drug can lead to an increase in ammonia in the blood in 1% of patients.The root cause of the event was found to be consistent with erwinase interference.No product problem was identified.

• 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: 18347475
• Report Number: 1823260-2023-04085
• Device Sequence Number: 5341960
• Product Code: JIF
• UDI-Device Identifier: 04015630936533
• UDI-Public: 04015630936533
• Combination Product (Y/N): Y
• Initial Reporter Country: NO
• 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): 02/05/2024

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: 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: 11/30/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 02/05/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ERWINASE
• Patient Sex: Female