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

Catalog Number	07P60-74
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.  note: this report is being filed on an international product, list number 07p60-74, which has a similar product distributed in the us, list number 07p60-21/-31.
Event or Problem Description
The customer observed false non-reactive alinity i syphilis tp result for a patient sample.The following data was provided (reference range 1.0 s/co is nonreactive): initial result = 0.70 s/co.Elisa results = positive, tppa results = positive, rpr results = negative.No impact to patient management was reported.
Event or Problem Description
The customer observed false non-reactive alinity i syphilis tp result for a patient sample.The following data was provided (reference range <1.0 s/co is nonreactive): initial result = 0.70 s/co.Elisa results = positive, tppa results = positive, rpr results = negative.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 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.Ticket search by lot indicates the reagent lot is performing as expected for this product.A review of tracking and trending did not identify any trends for the issue for the product.Device history record review for lot 52338be01 did not identify any non-conformances or deviations with the complaint lot.In-house testing of a retained reagent kit of the complaint lot was performed.All specifications were met, and no false non-reactive results were obtained, indicating that the lot generates the expected results.(note: lot 52338be01 is a china specific lot and is identical to lot 52338be00.Both contain the same bulk material and are identical except the labeling of the outer package).Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency with the alinity i syphilis tp reagent lot 52338be01, was identified.

• Brand Name: ALINITY I 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: 18416625
• Report Number: 3002809144-2023-00506
• Device Sequence Number: 16477436
• Product Code: LIP
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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: 05/16/2024
• Device Catalogue Number: 07P60-74
• Device Lot Number: 52338BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2023
• 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: ALNTY I PROCESSING MODU, 03R65-01, AI04646; ALNTY I PROCESSING MODU, 03R65-01, AI04646
• Patient Sex: Unknown