MAUDE Adverse Event Report: ABBOTT LABORATORIES TDX/TDXFLX METHOTREXATE II

Catalog Number	07A12-60
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided an evaluation is in process.A follow up report will be submitted when the evaluation is complete.Please note: this same patient/event is submitted under a second suspect medical device in manufacturer report number 1628664-2017-00248.
Event or Problem Description
The customer observed a falsely elevated methotrexate results on the tdx analyzer.The following data was provided: sid (b)(6) initial 9.41 micromol/l, repeat 0.55 mmol/l and 0.11 after 72 hours.There was no impact to patient management.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and accuracy testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The product was not available for return.An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications.A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: TDX/TDXFLX METHOTREXATE II
• Common Device Name: METHOTREXATE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 6631005
• Report Number: 1415939-2017-00131
• Device Sequence Number: 10764824
• Product Code: LAO
• UDI-Device Identifier: 00380740011635
• UDI-Public: 00380740011635
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K932615
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2017

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 Expiration Date: 11/08/2017
• Device Catalogue Number: 07A12-60
• Device Lot Number: 67031M501
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 06/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1