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

Catalog Number 08D06-42

Device Problem False Negative Result (1225)

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

Event Date 07/09/2021

Event Type  malfunction  

Event Description

The customer observed (b)(6) architect syphilis tp results for one patient.The following data was provided: on (b)(6)2021 sid (b)(6) (lot 21297be00) the patient was drawn for antenatal and generated a (b)(6) result of (b)(6) that was confirmed at the reference laboratoryon (b)(6) 2021 sid (b)(6) (lot 24362be00).The patient was drawn at sexual health and generated a (b)(6) result of (b)(6).On (b)(6) 2021 sid (b)(6) (lot 24362be00) generated a (b)(6) result of (b)(6).On (b)(6) 2021 the laboratory was made aware of the discrepancy and repeated the original sample from (b)(6) which generated a reactive result of (b)(6) (lot 25444be00).The sample from (b)(6) was discarded and could not be repeated.On (b)(6) 2021 sid (b)(6) (lot 25444be00) generated a (b)(6) result of (b)(6) on (b)(6) 2021 sid (b)(6) (lot 25444be00).The patient was drawn for antenatal and generated a (b)(6) result of (b)(6), the sample was sent to a reference laboratory which generated a (b)(6) result.Additional data was provided: trinity biotech captia ta eia total treponemal antibody = (b)(6).Fujirebio tppa = (b)(6).Axis shield rpr = (b)(6) no impact to patient management was reported.No impact to patient management was reported.

Manufacturer Narrative

Patient identifier: sids (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 8d06-74 has a similar product distributed in the us, list number 8d06-31/-41.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section g1 was corrected for updated contact information.

Event Description

The customer observed false negative architect syphilis tp results for one patient.The following data was provided: (b)(6) 2021 sid (b)(6) (lot 21297be00) the patient was drawn for antenatal and generated a reactive result of 1/12 s/co that was confirmed at the reference laboratory 08jul2021 sid (b)(6) (lot 24362be00) the patient was drawn at sexual health and generated a nonreactive result of 0.88 s/co (b)(6) 2021 sid (b)(6) (lot 24362be00) generated a nonreactive result of 0.97 s/co on 29nov2021 the laboratory was made aware of the discrepancy and repeated the original sample from june which generated a reactive result of 1.15 s/co (lot 25444be00).The sample from july was discarded and could not be repeated.(b)(6) 2021 sid (b)(6) (lot 25444be00) generated a nonreactive result of 0.89 s/co (b)(6) 2021 sid (b)(6) (lot 25444be00) the patient was drawn for antenatal and generated a nonreactive result of 0.89 s/co, the sample was sent to a reference laboratory which generated a reactive result.Additional data was provided: trinity biotech captia ta eia total treponemal antibody = positive fujirebio tppa = positive 1:160 axis shield rpr = negative no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false nonreactive architect syphilis tp results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, labeling review, and in-house testing.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review for lots 24362be00 and 25444be00 did not identify any non-conformances or deviations with the lot and complaint issue.In-house testing of a retained reagent kit of the complaint lots was performed.All controls met specifications and no false non-reactive results were obtained, showing that the lots generate the expected results.Labeling was reviewed and found to adequately address the issue under review.Based on our investigation, no systemic issue or deficiency with the architect syphilis tp reagent lots 24362be00 and 25444be00 were 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, IL N39 E-932 ; 2246682940
• MDR Report Key: 13282218
• MDR Text Key: 285225291
• Report Number: 3002809144-2022-00021
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Catalogue Number: 08D06-42
• Device Lot Number: 24362BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• 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, ISR07572; ARC I2000SR INST, 03M74-02, ISR07572; ARC I2000SR INST, 03M74-02, ISR07572; ARC SYPHILIS TP 500T, 08D06-42, 25444BE00; ARC SYPHILIS TP 500T, 08D06-42, 25444BE00; ARC SYPHILIS TP 500T, 08D06-42, 25444BE00