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

Catalog Number	08D06-41
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false nonreactive architect syphilis tp results for a newborn with a positive syphilis mother.The patient was redrawn and the expected positive result was obtained.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): initial result = 0.87 s/co sample was a short sample redraw sid (b)(6) result = 21.62 s/co no impact to donor management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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 testing of a retained reagent kit.Return testing was not completed as returns were not available.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.In-house testing of lot 59472be00, lot contains the same bulk material as lot 59466be00, 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 59466be00 was identified.
Event or Problem Description
The customer observed false nonreactive architect syphilis tp results for a newborn with a positive syphilis mother.The patient was redrawn and the expected positive result was obtained.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): initial result = 0.87 s/co sample was a short sample.Redraw sid (b)(6) result = 21.62 s/co no impact to donor 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: 19723886
• Report Number: 3002809144-2024-00202
• Device Sequence Number: 15490712
• Product Code: LIP
• UDI-Device Identifier: 00380740117122
• UDI-Public: (01)00380740117122(17)241113(10)59466BE00
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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: 11/13/2024
• Device Catalogue Number: 08D06-41
• Device Lot Number: 59466BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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, (B)(6). ; ARC I2000SR INST, 03M74-02, (B)(6).
• Patient Sex: Unknown