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

Catalog Number 08D06-32

Device Problem False Negative Result (1225)

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

Event Date 12/13/2021

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 08d06-32 that has a similar product distributed in the us, list number 08d06-31.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false non-reactive architect syphilis results generated on an architect i1000sr analyzer.Sid (b)(6) initial result on lot 30369be00 = 1.3251 s/co (reactive), repeat result = 1.3459 s/co (reactive) and 0.8070 s/co (nonreactive, from blood bag), repeat results on lot 28074be00 = 1.07 s/co (reactive) and 0.6045 s/co (nonreactive, from blood bag).Sample was processed on another instrument using lot 30369be00 generating a result = 1.3923 s/co (reactive).There was no impact to patient management reported.

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, and inhouse testing of a retained kit with the complaint lot number.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 and trending review did not identify any trends for likely cause lot and complaint issue.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Inhouse testing of a retained reagent kit of lot 28074be00 determined that all specifications were met, and no false non-reactive results were obtained, showing the lots generate the expected results.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency with the architect syphilis tp reagent lot 28074be00 was identified.

• Brand Name: ARCHITECT 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; 433331157
• MDR Report Key: 13253194
• MDR Text Key: 283781986
• Report Number: 3002809144-2022-00019
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2022
• Device Catalogue Number: 08D06-32
• Device Lot Number: 28074BE00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR MOD, 01L86-01, I1SR51092; ARC I1000SR MOD, 01L86-01, I1SR51092