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

Catalog Number ASKU

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 01/01/2003

Event Type  malfunction  

Event Description

There was an allegation of questionable plasma nh3l ammonia results for 4 patient samples on a hitachi 917 analyzer.For sample 1, the initial nh3 result was 163 umol/l.The sample was repeated in three 20 minute intervals and the results were 235 umol/l, 292 umol/l, and 315 umol/l.For sample 2, the initial nh3 result was 209 umol/l.The sample was repeated in three 20 minute intervals and the results were 272 umol/l, 351 umol/l, and 383 umol/l.For sample 3, the initial nh3 result was 201 umol/l.The repeat result was 276 umol/l.For sample 4, the initial nh3 result was 259 umol/l.The repeat result was 339 umol/l.

Manufacturer Narrative

The analyzer serial number was not provided.The study alleged that antineoplastic therapy with asparaginase can affect ammonia results in plasma samples.The study stated that asparaginase converts the amino acid asparagine to aspartic acid and ammonia and it appears from their observations that some ammonia production occurs in vitro after sample collection.The investigation is ongoing.

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: 18347471
• MDR Text Key: 331060780
• Report Number: 1823260-2023-04086
• Device Sequence Number: 1
• Product Code: JIF
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: ASKU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,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: ASKU
• 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?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPARAGINASE
• Patient Sex: Female