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

Catalog Number 07P60-74

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

Note: this report is being filed on an international product, list 07p60-74, that has a similar product distributed in the us, list number 07p60-21/-31.Section a1 - patient identifier complete entry = (b)(6) section e1 - phone number complete entry = (b)(6) all available patient information was included.Additional patient details are not available.  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 49616be01 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 49616be01 is a china specific lot and is identical to lot 49616be00).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 49616be01, was identified.

Event Description

The customer observed false non-reactive alinity i syphilis tp result for a 66-year-old male patient sample.The following data was provided (reference range <1.0 s/co is nonreactive): 19sep2023 sample id (b)(6) after high-speed centrifugation of the sample, retest result with lot number 49616be01= 0.61 s/co; initial result on another alinity with lot number 50281be01 = 0.57 s/co wantai platform initial result = 6.0 s/co, repeat = 6.4 s/co (reference range >1.0 s/co is positive), colloidal gold = positive tppa = weak positive, trust = negative.Sample sent to another hospital and ran on chemclin luminescence platform.Result = positive historical result in december 2022 = 0.51 s/co no impact to patient management was reported.

• Brand Name: ALINITY I 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: 18207815
• MDR Text Key: 328961559
• Report Number: 3002809144-2023-00475
• 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
• Report Date: 11/26/2023

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: 01/16/2024
• Device Catalogue Number: 07P60-74
• Device Lot Number: 49616BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALIN I SYPHILIS 200T CN, 07P60-74, 50281BE01; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Age: 66 YR
• Patient Sex: Male