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

Catalog Number 08D06-74

Device Problem False Negative Result (1225)

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

Event Date 08/27/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer questioned architect (b)(6) results for one patient.The following was provided: initial result (b)(6), repeated with another method (elisa) (b)(6) and a third method (tppa) (b)(6) and a fourth method (trust) (b)(6).A new draw was obtained and all results with the new sample were (b)(6).No impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for architect syphilis tp lot 26001be01.A review of tickets was performed and determined that the reagent lot performs as expected for this product.A review of tracking and trending did not identify any trends for the complaint issue.The customer provided the sample in question and this sample was tested in the course of investigation; results were: architect syphilis tp: 0.38 s/co (non-reactive), recomline treponema igm: negative and recomline treponema igg: borderline (tp453:+, tp15: +/-).In-house testing of retained reagent kits of lot numbers 23137be/26001be was performed.All controls met specifications and no false non-reactive results were obtained, showing that the lots generates the expected results.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect syphilis tp lot 26001be01 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
• MDR Report Key: 12442852
• MDR Text Key: 277987294
• Report Number: 3002809144-2021-00563
• 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: 11/02/2021

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: 11/26/2021
• Device Catalogue Number: 08D06-74
• Device Lot Number: 23137BE01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 10/13/2021
• Supplement Dates FDA Received: 11/02/2021
• 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: 67 YR