MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT SYPHILIS TP

Model Number	8D06-41
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being filed on an international product, architect syphilis tp, list 8d06-77, that has a similar product distributed in the us, list number 8d06-31/-41.Patient information: no specific patient information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer obtained a false negative architect syphilis tp result.The sample generated 0.13 and retest on second analyzer 0.15 s/co on architect.The sample generated positive results on tppa and rpr methods.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for a false non-reactive result for one sample tested with the architect syphilis tp assay included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and inhouse testing of retained kits with the complaint lot number.Complaint activity and trending review identified no issues or trends associated with the complaint issue.Device history record review for the complaint lot did not identify any related non-conformances or deviations.A retained reagent kit of the complaint lot was tested in a sensitivity setup.No false non-reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.Based on our investigation, no systemic issue or deficiency of the architect syphilis tp reagent lot was identified.
Event or Problem Description
The customer obtained a false negative architect syphilis tp result.The sample generated 0.13 and retest on second analyzer 0.15 s/co on architect.The sample generated positive results on tppa and rpr methods.No impact to patient management was reported.No impact to patient management was reported.

• 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: 10545738
• Report Number: 3002809144-2020-00932
• Device Sequence Number: 19616749
• Product Code: LIP
• UDI-Device Identifier: 00380740117122
• UDI-Public: 00380740117122
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2020

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: 10/28/2020
• Device Model Number: 8D06-41
• Device Catalogue Number: 08D06-77
• Device Lot Number: 10543BE01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 11/25/2020
• 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: ARC I2K PROC MOD, 03M74-01, SERIAL (B)(4); ARCHITECT I2000SR, LIST 03M74-01,; SERIAL (B)(4); ARCHITECT I2000SR, LIST 03M74-01,; SERIAL (B)(4)