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

Catalog Number 06P09-55

Device Problem False Positive Result (1227)

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

Event Date 12/01/2021

Event Type  malfunction  

Event Description

The customer noticed an increase in initial and repeat reactive rates for the alinity s syphilis assay in the months of (b)(6) 2021 and (b)(6) 2022 on both alinity s analyzers (as1076 and as1079) using the same lot numbers of reagent.The following are the total number of reactive results provided by the customer for (b)(6) 2021.Assay: new donor, returning donor (not previously reactive), returning donor (previously reactive).Syphilis: 2, 4, 2.The reactive results for the 4 donors that were previously nonreactive are considered to be potentially false reactive.No adverse impact to patient/donor management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 06p09-55, that has a similar product distributed in the us, list number 08d06-31 and 08d06-41.

Manufacturer Narrative

Trending review determined no adverse trend for the issue for the product.Historical complaint review determined there is normal complaint activity for the lot number.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.A customer data review for the complaint lot was performed.The analysis included initial reactive rates (irr), repeat reactive rates (rrr) and specificity (assuming zero prevalence) at scottish national bts (snbts), across whole blood (wb) peer sites and all ous customer sites.Aggregated performance of the complaint lot across all ous customer sites (regardless of peer group) and selected wb peer sites is within product requirements and comparable to the performance of other lots of the same assay evaluated in the comparison.The reactive rates and specificity of the complaint lot at snbts is within product requirements and comparable to the performance at peer sites.Additionally, a review of the overall monthly reactive rates from march 2021 to january 2022 was performed for for the complaint lot.The performance of the assay across all months is within product requirements.Based on the investigation, no deficiency for lot number 27526be00 was identified.The device met performance specifications and performed as intended at the customer site as the obtained reactive rates and specificity were within product requirements.

• Brand Name: ALINITY S SYPHILIS 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 13537162
• MDR Text Key: 288382022
• Report Number: 3002809144-2022-00058
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2022
• Device Catalogue Number: 06P09-55
• Device Lot Number: 27526BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01, AS1076; ALNTY S SYSTEM, 06P16-01, AS1076; ALNTY S SYSTEM, 06P16-01, AS1079; ALNTY S SYSTEM, 06P16-01, AS1079