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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.Patient identifier sids: (b)(6).This report is being filed on an international product, list number 8d06-77 that has a similar product distributed in the us, list number 8d06-41.

Event Description

The customer reported (b)(6) architect syphilis tp results on two patients.Results provided: sid (b)(6) = (b)(6), re-tested under sid (b)(6) = (b)(6); sid (b)(6) = (b)(6), re-tested under sid (b)(6) = (b)(6).No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false non-reactive results 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.Return testing was not completed as returns were not available.A review of complaints for architect syphilis tp reagent lot 28248be01 identified normal complaint activity and there are no trends for the product related to patient results.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Inhouse testing determined that the sensitivity performance is not negatively impacted.A review of the product labeling concluded that the issue is sufficiently addressed.Based on our investigation no systemic issue or product deficiency of the architect syphilis tp reagent lot 28248be01 was identified.

• 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
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12638995
• MDR Text Key: 278012268
• Report Number: 3002809144-2021-00602
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K153730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

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: 03/31/2022
• Device Catalogue Number: 08D06-77
• Device Lot Number: 28248BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR62031