MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT SYPHILIS TP

Model Number	8D06-31
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a false reactive architect (b)(6) tp result and was inquiring if the assay has any cross reactivity with red cell antigens.The following data was provided for the patient in question: initial result = 1.71 s/co (reactive), mha tp = reactive, rpr = nonreactive.The patient is positive for the "c" antigen and recently delivered a baby.The newborn baby had a spinal tap procedure to retrieve cerebrospinal fluid for (b)(6) testing: architect (b)(6) = reactive, rpr = nonreactive, mha tp = nonreactive, vdrl = nonreactive.The spinal tap was performed due to the false reactive architect (b)(6) results on the mother's sample.
Additional Manufacturer Narrative
A review of tickets was performed for reagent lot number 05464be00.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A retained reagent kit of lot number 05464be00 was tested in a specificity setup, including additional replicates of a specificity panel.Results of this setup did not implicate that the performance regarding specificity of the lot is negatively impacted as no false reactive results were obtained.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect syphilis tp assay for lot 05464be00 was identified.

• Brand Name: ARCHITECT SYPHILIS TP
• Common Device Name: SYPHILIS
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9527284
• Report Number: 3002809144-2019-01095
• Device Sequence Number: 11436847
• Product Code: MTN
• UDI-Device Identifier: 00380740117115
• UDI-Public: 00380740117115
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/03/2020
• Device Model Number: 8D06-31
• Device Catalogue Number: 08D06-31
• Device Lot Number: 05464BE00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I1000SR PROCESSING MODULE; ARCHITECT I1000SR PROCESSING MODULE; LIST 01L86-40, SERIAL (B)(4); LIST 01L86-40, SERIAL (B)(4)
• Outcome Attributed to Adverse Event: Disability