MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ONLINE TDM METHOTREXATE; ENZYME IMMUNOASSAY, METHOTREXATE

Catalog Number	09230785190
Medical Device Problem Codes	High Test Results (2457); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable methotrexate (mtx) results from the cobas 8000 cobas c 502 module.The initial test gave no numeric result but had a data flag indicating the result was greater than the test range.The repeat result with a 1:10 dilution gave no numeric result but had a data flag indicating the result was greater than the test range.The customer repeated the sample with a 1:100 manual dilution and the result was 218 umol/l.The neat sample and the 1:10 dilution sample were tested on another analyzer and gave no numeric result but had a data flag indicating the result was greater than the test range.On the other analyzer, the customer repeated the sample with a 1:100 manual dilution and the result was 110 umol/l.The questionable results were not reported outside of the laboratory.The repeat result was believed correct.
Additional Manufacturer Narrative
The reagent lot number and expiration date were requested but were not provided.The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch fields d1-d4, g1, and g4 were updated.The field service engineer found the cause to be an operator handling issue when performing manual dilutions.He instructed the user to load new methotrexate reagents and recalibrate the assay.Afterward, qc passed.

• Brand Name: ONLINE TDM METHOTREXATE
• Common Device Name: ENZYME IMMUNOASSAY, METHOTREXATE
• 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 46250-0457
• MDR Report Key: 19032525
• Report Number: 1823260-2024-01021
• Device Sequence Number: 7497982
• Product Code: LAO
• UDI-Device Identifier: 07613336224816
• UDI-Public: 07613336224816
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K233454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024
• 2 Devices were Involved in the Event: 1 2

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: 09230785190
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 06/05/2024
• 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
• Patient Sex: Unknown