MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT SYPHILIS TP REAGENT KIT; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Catalog Number 08D06-77

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2020

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 08d06-77 that has a similar product distributed in the us, list number 8d06-31 / 41.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a false nonreactive architect (b)(6) tp result on a (b)(6) year-old male patient.The initial result was 0.66 s/co and the repeat result was 0.65 s/co (< 1.00 s/co = nonreactive).The patient had hard chancre and underwent microscopic examination for treponema pallidum; the tppa titer was positive (1:1280).No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation 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 testing of an inhouse retained kit of the complaint lot number.Return testing was not completed as returns were not available.Review of tracking and trending reports did not identify any related trends for the issue for the product.A review of the manufacturing documentation did not identify any issues associated with the lot and the complaint issue.A review of the product labeling concluded that the issue is adequately addressed.A retained reagent kit of the complaint lot was tested in a specificity setup.All specifications were met, and no false reactive results were obtained, indicating that the specificity performance is acceptable.Based on the investigation, no systemic issue or deficiency with the architect syphilis tp reagent lot(s) was identified in the complaint.

• Brand Name: ARCHITECT SYPHILIS TP REAGENT KIT
• Type of Device: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11014198
• MDR Text Key: 241306729
• Report Number: 3002809144-2020-01186
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• PMA/PMN Number: K153730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2021
• Device Catalogue Number: 08D06-77
• Device Lot Number: 12693BE01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(4); ARC I2000SR INST, 03M74-02, (B)(4)
• Patient Age: 33 YR