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 08/30/2021

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 08d06-31/-41.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a (b)(6) architect syphilis tp result for a (b)(6) year old male patient with kidney disease.The following data was provided (b)(6): laboratory department = initial architect (b)(6) result = (b)(6) / immunology lab¿s (b)(6) result by elisa = (b)(6).When retested on the architect analyzer the result was (b)(6) and the elisa result was (b)(6).On (b)(6) 2021, the patient tested at another hospital for (b)(6) and generated a (b)(6)result (b)(6) using another architect analyzer for troubleshooting purposes.The customer retested the sample using the ortho-clinical to retest the sample and generated a result of (b)(6), and the autobio test generated a (b)(6) result.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for observed false non-reactive architect syphilis tp results included a search for similar complaints, and the review of the complaint text, trending data, labeling, and device history records.Return sample analysis: the returned specimen samples were tested with the following results: sample id 378 = architect syphilis tp: 0.71 s/co (non-reactive), recomline treponema igm: negative, recomline treponema igg: negative.Sensitivity testing was done using an in-house retained kit of lot 25445be01 was performed.All specifications were met, and no false reactive results were obtained, showing that the lot generates the expected results.Trending review determined no trends were identified for the product for the issue.Device history record was reviewed and did not identify any non-conformances or deviations with reagent lot 25445be01 and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency for architect syphilis tp reagent lot 25445be01 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: 12450457
• MDR Text Key: 277989301
• Report Number: 3002809144-2021-00566
• 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: 10/13/2021

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: 01/11/2022
• Device Catalogue Number: 08D06-77
• Device Lot Number: 25445BE01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 10/13/2021
• 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: 67 YR