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

Catalog Number	08D06-31
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a false nonreactive architect syphilis tp result for one sample.The following data was provided: sid (b)(6) : architect (b)(6) result was nonreactive, titer was >256, arup result was reactive for troubleshooting purposes only, the sample was sent to another laboratory and repeated on another architect (b)(6) which generated nonreactive results.No impact to patient management was reported.
Additional 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, and in-house.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A search for similar complaints did not identify an increase in complaint activity for lot 54395be00.Ticket trending review did not identify any related trends for the issue for the product.Device history review did not identify any non-conformances or deviations with lot 54395be00 and the complaint issue.In-house testing of a retained kit of lot 54395be00 was performed.All controls met specifications and no false non-reactive results were obtained, showing that the lot generates the expected results.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 54395be00 was identified.
Event or Problem Description
The customer observed a false nonreactive architect syphilis tp result for one sample.The following data was provided: sid (b)(6) : architect (isr51054) result was nonreactive, titer was >256, arup result was reactive for troubleshooting purposes only, the sample was sent to another laboratory and repeated on another architect (isr62437) which generated nonreactive results.No impact to patient management was reported.

• Brand Name: ARCHITECT SYPHILIS TP REAGENT KIT
• Common Device Name: 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: 18314130
• Report Number: 3002809144-2023-00493
• Device Sequence Number: 6152491
• Product Code: LIP
• UDI-Device Identifier: 00380740117115
• UDI-Public: 00380740117115
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K153730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/13/2024
• Device Catalogue Number: 08D06-31
• Device Lot Number: 54395BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2000SR INST, 03M74-02, ISR51054; ARC I2000SR INST, 03M74-02, ISR51054; ARC I2000SR INST, 03M74-02, ISR62437; ARC I2000SR INST, 03M74-02, ISR62437
• Patient Sex: Unknown