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 12/20/2023

Event Type  malfunction  

Event Description

The customer observed false nonreactive architect syphilis tp results for one patient sample.The following data was provided (reference range: < 1.00 s/co is nonreactive, >/= 1.00 s/co is reactive): architect syphilis result = 0.41 s/co (nonreactive).Tppa result = positive.Elisa result = 4.48 s/co (positive).Autobio result = 2.94 s/co (positive) there was no impact to patient management reported.

Manufacturer Narrative

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

Event Description

The customer observed false nonreactive architect syphilis tp results for one patient sample.The following data was provided (reference range: < 1.00 s/co is nonreactive, >/= 1.00 s/co is reactive): architect syphilis result = 0.41 s/co (nonreactive).Tppa result = positive.Elisa result = 4.48 s/co (positive).Autobio result = 2.94 s/co (positive) there was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, in house testing of a retained reagent kit, and return specimen testing.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends regarding commonalities for complaint lot.Device history review did not identify any non-conformances or deviations with the complaint lot.The returned specimen was tested with the following results: sample id (b)(6).Architect syphilis tp: 0.46 s/co (non-reactive).Recomline treponema igm: negative.Recomline treponema igg: negative.During in-house testing a non-reactive result was generated for the return sample with lot 50319be01.No discrepant results were obtained.In-house testing of lot 52310be00, lot number contains the same bulk material as lot number 52310be01, was completed using panels which mimic patient samples using an in-house retained kit.All specifications were met indicating the lot is performing acceptably.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect syphilis tp reagent lot 52310be01 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18410738
• MDR Text Key: 331687754
• Report Number: 3002809144-2023-00504
• 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: 02/29/2024

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: 05/12/2024
• Device Catalogue Number: 08D06-77
• Device Lot Number: 52310BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2023
• 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)