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 04/09/2024

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 08d06-77 that has a similar product distributed in the us, list number 08d06-31/-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 architect syphilis tp result generated on the architect i2000sr analyzer for a 10-year-old male.The syphilis results are inconsistent with other platform methods.The following data was provided: architect syphilis result = 0.28 s/co.The physician simultaneously requested tppa and trust testing for the sample.The tppa was weakly positive, and the trust titer result was 1:1.The customer also tested the patient sample using the elisa method and generated a negative result.The customer ran the sample on the roche platform and obtained a result of 1.28 s/co (weakly positive).After checking the patient¿s medical history, his syphilis test was weakly positive on other platforms during appendicitis surgery in the local hospital (the specific platform is unknown).The father¿s syphilis test was negative, and the mother¿s syphilis test was unknown.There was no impact to patient management reported.

Manufacturer Narrative

Upon further review, it was found that section d4 - expiration date needed to be updated with the correct date of 7/13/2024 instead of 7/12/2024.D4 - primary udi number will also be updated to accommodate the corrected date.B5 -describe event or problem - on 22may2024, additional information was received.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 review, and in house testing of a retained reagent kit lot 54393be01.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.A search for similar complaints did identify a slight increase in complaint activity for lot 54393be01, however, no related trends were identified regarding commonalities for complaint lot number and issue.Additionally, in-house testing was completed using panels which mimic patient samples using an in-house retained kit.All specifications were met indicating the lot is performing as expected.Device history review did not identify any non-conformances or deviations associated with the lot number 54393be01 and complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.In this case, the negative architect syphilis tp result is in accordance with the negative elisa result and the customer suspected the tppa result as a false positive.Based on the investigation, architect syphilis tp reagent lot 54393be01 is performing as intended, no systemic issue or product deficiency was identified.

Event Description

The customer reported a false nonreactive architect syphilis tp result generated on the architect i2000sr analyzer for a 10-year-old male.The syphilis results are inconsistent with other platform methods.The following data was provided: architect syphilis result = 0.28 s/co.The physician simultaneously requested tppa and trust testing for the sample.The tppa was weakly positive, and the trust titer result was 1:1.The customer also tested the patient sample using the elisa method and generated a negative result.The customer ran the sample on the roche platform and obtained a result of 1.28 s/co (weakly positive).After checking the patient¿s medical history, his syphilis test was weakly positive on other platforms during appendicitis surgery in the local hospital (the specific platform is unknown).The father¿s syphilis test was negative, and the mother¿s syphilis test was unknown.Update: on 22may2024, the customer believed the tppa result was false weak positive since the abbott result and elisa result both generated a negative result.The customer sent the negative abbott result, negative elisa result, the trust result of 1:1, and the weak positive tppa result and recommended to retest after 1 month.There was no impact to patient management reported.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19113081
• MDR Text Key: 340902068
• Report Number: 3002809144-2024-00114
• Device Sequence Number: 1
• Product Code: LIP
• UDI-Device Identifier: 00380740161934
• UDI-Public: (01)00380740161934(17)240712(10)54393BE01
• 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
• Report Date: 04/15/2024

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 Catalogue Number: 08D06-77
• Device Lot Number: 54393BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2023
• 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, ISR64654.; ARC I2000SR INST, 03M74-02, ISR64654.
• Patient Age: 10 YR
• Patient Sex: Male