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

Catalog Number 06P09-55

Device Problem False Negative Result (1225)

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

Event Date 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: sid (b)(6) (same patient / 2 different samples).This report is being filed on an international product, list number 06p09-55 that has a similar product distributed in the us, list number 8d06-31/-41.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a false nonreactive alinity s syphilis tp result for a donor who has a medical history of being reactive when tested for syphilis previously.The following data was provided (reference range: < 1.00 s/co is nonreactive, >/= 1.00 s/co is reactive): on (b)(6) 2022 sid (b)(6): initial result: 6.79 s/co (alinity 2 as1082); repeat results: 7.22, 6.92 s/co (alinity 1 as1245 on (b)(6) 2022) on (b)(6) 2022, same donor enters as a patient by the doctor¿s request: sid (b)(6): initial result: 0.70 s/co, result released as nonreactive (alinity 3 as1292) the doctor questioned this result and both samples were retested.The repeat results were: (b)(6) 2022: sid (b)(6) (second sample): 7.13 s/co (alinity 3 as1292).Sid (b)(6) (second sample): 7.45 s/co (alinity 1 as1245).On (b)(6) 2022: sid (b)(6) (first sample): 6.07 s/co (alinity 1 as1245) there was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false nonreactive alinity s syphilis tp results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.Evaluation of complaint data for the product and reagent lot 31359be00 identified normal complaint activity for the complaint issue.A review of tracking and trending determined that there were no related trends identified.A retained kit of alinity s syphilis reagent, (b)(6), lot 31359be00, was calibrated and the calibrations met instrument specifications.All control values met control specifications and were in the typical range.To evaluate clinical sensitivity, 112 replicates of syphilis tp secondary positive control were tested.The replicates of the positive control met specifications.No false non-reactive results were obtained.Further a commercially available seroconversion panel (seracare syphilis seroconversion (b)(6)) was tested.Alinity s syphilis reagent, (b)(6), lot 31359be00 detected the same first bleed as reactive as compared to historical data.The device history record was reviewed and did not identify any non-conformances, potential non-conformances and deviations related to reagent lot 31359be00 and complaint issue.Labeling was reviewed and concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or product deficiency for alinity s syphilis tp reagent lot 31359be00 was identified.

• 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: 15097585
• MDR Text Key: 298198338
• Report Number: 3002809144-2022-00259
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2022
• Device Catalogue Number: 06P09-55
• Device Lot Number: 31359BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• 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, (B)(6); ALNTY S SYSTEM, 06P16-01, (B)(6)