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 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 08d06-77 that has a similar product distributed in the us, list number 08d06-31/41.

Event Description

The customer observed (b)(6) architect (b)(6) results on one (b)(6) female patient diagnosed with hyperthyroidism.The results provided were: on (b)(6) 2021 sid (b)(6) initial (b)(6).Roche electrochemiluminescence method at another hospital= (b)(6) /colloidal gold and boson chemiluminescence method = (b)(6)/ (b)(6) 2020 euroimmun western blotting igm= (b)(6) there was no reported impact to patient management.

Manufacturer Narrative

Health effect impact code: f26 component code: g01003 d8: was this device serviced by a third party?: no the complaint evaluation 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 retained kit of the architect syphilis tp reagent lot 21298be01.Trending review determined no adverse trend for the issue for the product.A 12-month tracking and trending review identified a non-statistical trend for an increase in complaints related to false reactive/elevated patient results/high reactive rates for lot 21298be01.The returned specimen (b)(6) was tested with syphilis, lot number 18322be01, recomline treponema igm, recomline treponema igg and architect syphilis tp.(b)(6) generated 0.16 s/co (non-reactive); recomline treponema igm; borderline; recomline treponema igg = negative specificity testing was performed with a retained kit of lot 21298be01.All controls met specifications and no false non-reactive results were obtained, indicating that the specificity performance is not negatively impacted.Device history record review did not identify any non-conformances or deviations with the likely cause lot(s) and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect syphilis tp reagent lot 21298be01.

Manufacturer Narrative

This follow-up submission sends for correction on section d9 in emdr (b)(6) 2021 form version: date returned to mfg: to blank (no date) from (b)(6) 2021 in d10 in emdr form version 2018.This date (b)(6) 2021 was not for the suspect device return and it reflected the date patient specimens were returned for investigation.

• 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: 11230298
• MDR Text Key: 244470950
• Report Number: 3002809144-2021-00056
• 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,Followup
• Report Date: 06/14/2021

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: 09/21/2021
• Device Catalogue Number: 08D06-77
• Device Lot Number: 21298BE01
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 03/09/2021; 06/14/2021
• Supplement Dates FDA Received: 03/10/2021; 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR51637; ARC I2000SR INST, 03M74-02, ISR51637; ARC I2000SR INST, 03M74-02, ISR51637
• Patient Age: 31 YR