MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT SYPHILIS TP

Catalog Number	08D06-31
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a false non-reactive architect syphilis tp result for one postpartum patient that was previously treated for (b)(6).Sample id (b)(6) generated a negative (0.14 s/co) result on the architect assay and positive on the rpr assay.The customer further indicated the baby was also positive on rpr.No further patient information was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, in-house testing, and a review of labeling.Ticket searches determined that there is normal complaint activity for likely cause lot 77075li00.Tracking and trending report review for the (b)(6) assay determined that there are no related adverse or non-statistical trends.A retained reagent kit of lot number 77075li00 was tested in a sensitivity setup, including additional replicates of a sensitivity panel.Results of this setup did not implicate that the performance of the lot was negatively impacted.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect syphilis tp assay was identified.Update 2017 dec 04: initial mdr, serial number field incorrectly contained (b)(4).This field was corrected and left blank.

• Brand Name: ARCHITECT SYPHILIS TP
• Common Device Name: SYPHILIS
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 6965649
• Report Number: 3002809144-2017-00137
• Device Sequence Number: 1364870
• Product Code: MTN
• UDI-Device Identifier: 00380740117115
• UDI-Public: 00380740117115
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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): 12/04/2017

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: 04/26/2018
• Device Catalogue Number: 08D06-31
• Device Lot Number: 77075LI00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1