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

Catalog Number 08D06-77

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.  phone complete entry: (b)(6).

Event Description

The customer observed a false non-reactive architect syphilis tp result for a 63 year old male patient.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): sample id: (b)(6), initial result = 0.08 s/co, repeat result = 0.09 s/co, rapid plasma reagin (rpr) = 1:16 (positive).No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false nonreactive architect syphilis results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history review, in house testing of a retained reagent kit, and return sample testing was completed.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 37093be01 and the complaint issue.In-house testing of a retained reagent kit of the complaint lot was performed.All controls met specifications and no false non-reactive results were obtained, indicating that the lot generates the expected results.Labeling was reviewed and sufficiently addresses the customer's issue.The returned specimen sample id (b)(6) was tested with the following results: architect syphilis tp: 0.09 s/co (non-reactive), recomline treponema igm: negative, recomline treponema igg: negative.In-house testing of the return sample was performed with architect syphilis tp lot 41106be01, due to the complaint lot 37093be01 not being available for testing.No discrepant results were generated.Based on the investigation, no systemic issue or deficiency with the architect syphilis reagent lot 37093be01 was identified.

Event Description

Additional information was provided but the customer stating that after sending the sample for confirmatory testing, the result was negative, which was consistent with the abbott platform result.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15742845
• MDR Text Key: 307473339
• Report Number: 3002809144-2022-00386
• 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: 12/01/2022

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: 01/28/2023
• Device Catalogue Number: 08D06-77
• Device Lot Number: 37093BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• 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, (B)(6) ; ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Age: 63 YR
• Patient Sex: Male