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

Catalog Number 07236450190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 331060383
• Report Number: 1823260-2023-04085
• Device Sequence Number: 1
• Product Code: JIF
• UDI-Device Identifier: 04015630936533
• UDI-Public: 04015630936533
• Combination Product (y/n): Y
• Reporter Country Code: NO
• PMA/PMN Number: K972250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07236450190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ERWINASE
• Patient Sex: Female