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

Catalog Number 08D06-77

Device Problem False Negative Result (1225)

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

Event Date 10/08/2021

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, architect syphilis tp, list 8d06-77, that has a similar product distributed in the us, list number 8d06-31 and 8d06-41.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient information: no specific patient information was provided.

Event Description

The customer obtained (b)(6) architect syphilis tp results.Sample id (b)(6) generated (b)(6) and retest with sample id (b)(6) on architect.The sample was (b)(6) on tppa (b)(6).No impact to patient management was reported.

Manufacturer Narrative

The investigation of the customer's issue included review of complaint activity, trending data, labeling, device history records and the complaint text.Additionally, in house testing of a retained kit and return sample analysis were completed.Trending report review for the architect syphilis tp assay did not identify any trends.Device history record review for the complaint lot did not identify any non-conformances or deviations for the complaint issue.Labeling was reviewed and sufficiently addresses the complaint issue.The returned specimen sample h224 was tested with an alternate reagent lot of architect syphilis tp.The sample generated a non-reactive result of 0.06 s/co.Although there is no reference test method for the syphilis assay, the sample was also tested on recomline treponema igm, recomline treponema igg methods which also generated negative results.Additionally, in-house testing of a retained kit of lot 25445be00 (which contains the same bulk material as 25445be01) was performed.All controls met specifications and no false non-reactive results were obtained, showing that the lot generates the expected results.Based on this investigation, no systemic issue or deficiency of the architect syphilis reagent lot was identified.

Manufacturer Narrative

Section d9 date returned to manufacturer was incorrectly entered with the date the sample was returned in the previous follow up.The reagent kit was not returned, therefore the field should have remained blank and has been corrected.Section g1 contact information was updated to reflect the current contact (b)(6).

• 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, IL N39 E-932 ; EI N39 E932 ; 2246682940
• MDR Report Key: 12668689
• MDR Text Key: 278015427
• Report Number: 3002809144-2021-00611
• 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,Followup,Followup
• Report Date: 02/04/2022

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: 01/11/2022
• Device Catalogue Number: 08D06-77
• Device Lot Number: 25445BE01
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 11/09/2021; 02/03/2022
• Supplement Dates FDA Received: 11/23/2021; 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR64112