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

Catalog Number 07P60-32

Device Problem False Positive Result (1227)

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

Event Date 09/22/2023

Event Type  malfunction  

Event Description

The customer obtained non-reactive alinity i syphilis tp for 1 patient, and is stating that the results were not consistent with patient¿s history.The customer provided the following data (reference < 1.0 s/co is non-reactive).On (b)(6) 2023 ¿ syphilis result was 0.65 (non-reactive), generated from reagent lot: 50282be00, tested on alinity (b)(6).Historical syphilis results: on (b)(6) 2018 ¿ syphilis: reactive 11.62 s/co (abbott architect platform), vdrl: reactive.On (b)(6) 2019 ¿ syphilis: reactive (siemens platform), vdrl: non-reactive.On (b)(6) 2020 ¿ syphilis: reactive (siemens platform), vdrl: non-reactive.On (b)(6) 2020 ¿ syphilis: reactive (siemens platform), vdrl: non-reactive there was no reported impact to patient management.

Manufacturer Narrative

This report is being filed on an international product, list number 7p60-32 and there is a similar product distributed in the us, list number 07p60-21 / 31.E1 phone: complete phone number: (b)(6).All available patient information was included.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer obtained non-reactive alinity i syphilis tp for 1 patient, and is stating that the results were not consistent with patient¿s history.The customer provided the following data (reference < 1.0 s/co is non-reactive).(b)(6) 2023 ¿ syphilis result was 0.65 (non-reactive), generated from reagent lot 50282be00, tested on alinity (b)(6).Historical syphilis results: (b)(6) 2018 ¿ syphilis: reactive 11.62 s/co (abbott architect platform), vdrl: reactive.(b)(6) 2019 ¿ syphilis: reactive (siemens platform), vdrl: non-reactive.(b)(6) 2020 ¿ syphilis: reactive (siemens platform), vdrl: non-reactive.(b)(6) 2020 ¿ syphilis: reactive (siemens platform), vdrl: non-reactive there was no reported impact to patient management.

Manufacturer Narrative

Section h6 - adverse event problem, type of investigation coding was corrected.

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.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.Device history review did not identify any non-conformances or deviations with the complaint lot.The ticket search by lot indicates that the reagent lot 50282be00 perform as expected for this product.Ticket and trending review did not identify any related trends regarding commonalities for complaint lot numbers and customer issue.In-house testing was conducted on lot number 50281be01, which contains the same bulk material as, lot number 50282be00, and concluded which determined that all controls met specifications and no false non-reactive results were obtained.In house testing concluded that the expected results were generated.Labeling was reviewed and was found to address the customer reported issue.Based on the investigation, no systemic issue or deficiency was identified for alinity i syphilis tp reagent, lot number 50282be00.

Event Description

The customer obtained non-reactive alinity i syphilis tp for 1 patient, and is stating that the results were not consistent with patient¿s history.The customer provided the following data (reference < 1.0 s/co is non-reactive) (b)(6) 2023 ¿ syphilis result was 0.65 (non-reactive), generated from reagent lot 50282be00, tested on alinity (b)(6) historical syphilis results: (b)(6) 2018 ¿ syphilis: reactive 11.62 s/co (abbott architect platform), vdrl: reactive (b)(6) 2019 ¿ syphilis: reactive (siemens platform), vdrl: non-reactive (b)(6) 2020 ¿ syphilis: reactive (siemens platform), vdrl: non-reactive (b)(6) 2020 ¿ syphilis: reactive (siemens platform), vdrl: non-reactive there was no reported impact to patient management.

• 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: 17928267
• MDR Text Key: 325802052
• Report Number: 3002809144-2023-00429
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 01/04/2024

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: 03/13/2024
• Device Catalogue Number: 07P60-32
• Device Lot Number: 50282BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 01/04/2024; 01/04/2024
• Supplement Dates FDA Received: 01/04/2024; 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)