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

Catalog Number 08D06-74

Device Problem False Negative Result (1225)

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

Event Date 11/21/2023

Event Type  malfunction  

Event Description

The customer reported false non-reactive architect syphilis tp, and provided the following data: customer reference = 1.0 s/co is reactive on 21 nov 2023, sample id (b)(6) initial abbott result was 0.7 (non-reactive), repeat result was 0.69 (non-reactive) the sample was also tested further with the following testing methods/platforms and results: bioscience result was 5.53 s/co (positive) industrial scientific result was 1.406 s/co (cutoff>1, positive), the wantai result was 1.313 s/co (cutoff>1, positive), the elisa result was 1.454, (positive).The customer did not use trust and tppa methodologies, however the customer reported that they may perform further confirmatory testing.Patient information: 53 year-old male, admitted to the hospital for diabetes and poor control of blood sugar, suspected of having metastatic lung cancer.Per the customer the discrepant result(s) were not reported out of the laboratory.There was no reported impact to patient management.

Manufacturer Narrative

This report is being filed on an international product, list number 08d06-74 and there is a similar product distributed in the us, list number 8d06-31 / 41.E1 phone: complete phone number is (b)(6).All available patient information was included.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported false non-reactive architect syphilis tp, and provided the following data: customer reference = 1.0 s/co is reactive.On (b)(6) 2023, sample id 180 initial abbott result was 0.7 (non-reactive), repeat result was 0.69 (non-reactive).The sample was also tested further with the following testing methods/platforms and results: bioscience result was 5.53 s/co (positive) industrial scientific result was 1.406 s/co (cutoff>1, positive), the wantai result was 1.313 s/co (cutoff>1, positive), the elisa result was 1.454, (positive).The customer did not use trust and tppa methodologies, however the customer reported that they may perform further confirmatory testing.Patient information: 53 year-old male, admitted to the hospital for diabetes and poor control of blood sugar, suspected of having metastatic lung cancer.Per the customer the discrepant result(s) were not reported out of the laboratory.There was no reported impact to patient management.

Event Description

The customer reported false non-reactive architect syphilis tp, and provided the following data: customer reference = 1.0 s/co is reactive.On 21 nov 2023, sample id 180 initial abbott result was 0.7 (non-reactive), repeat result was 0.69 (non-reactive).The sample was also tested further with the following testing methods/platforms and results: bioscience result was 5.53 s/co (positive) industrial scientific result was 1.406 s/co (cutoff>1, positive), the wantai result was 1.313 s/co (cutoff>1, positive), the elisa result was 1.454, (positive).The customer did not use trust and tppa methodologies, however the customer reported that they may perform further confirmatory testing.Patient information: 53 year-old male, admitted to the hospital for diabetes and poor control of blood sugar, suspected of having metastatic lung cancer.Per the customer the discrepant result(s) were not reported out of the laboratory.There was no reported impact to patient management.

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 review, and in house testing.Return testing was completed as specimen sample was returned for testing.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Device history review did not identify any related nonconformances or deviations associated with the likely cause lot number and complaint issue.Ticket search by lot did not identify an increase in complaint activity for the complaint lot.The review of ticket and trending concluded that there were no identified trends regarding commonalities for lot number and customer issue.In house testing was performed on lot 54393be00, which contains the same bulk material lot 54393be01.In house testing concluded all controls met specifications and no false non-reactive results were obtained, indicating that the lot generates the expected results.Labeling was reviewed and was found to address the customer reported issue.The returned specimen sample was tested on architect syphilis tp as complaint lot 54393be01 was not available for testing.Testing generated the following results: architect syphilis tp: 0.72 s/co (non-reactive), recomline treponema igm: negative, recomline treponema igg: negative.No discrepant results were obtained from returned specimen sample testing.Based on the available information, no systemic issue or deficiency was identified for the architect syphilis tp reagent, lot number 54393be01.Section d4 - lot was corrected.

Event Description

The customer reported false non-reactive architect syphilis tp, and provided the following data: customer reference = 1.0 s/co is reactive.On (b)(6) 2023, sample id (b)(6) initial abbott result was 0.7 (non-reactive), repeat result was 0.69 (non-reactive).The sample was also tested further with the following testing methods/platforms and results: bioscience result was 5.53 s/co (positive) industrial scientific result was 1.406 s/co (cutoff>1, positive), the wantai result was 1.313 s/co (cutoff>1, positive), the elisa result was 1.454, (positive).The customer did not use trust and tppa methodologies, however the customer reported that they may perform further confirmatory testing.Patient information: 53 year-old male, admitted to the hospital for diabetes and poor control of blood sugar, suspected of having metastatic lung cancer.Per the customer the discrepant result(s) were not reported out of the laboratory.There was no reported impact to patient management.

Manufacturer Narrative

Section d4 - lot was corrected.

Event Description

The customer reported false non-reactive architect syphilis tp, and provided the following data: customer reference = 1.0 s/co is reactive on (b)(6) 2023, sample id 180 initial abbott result was 0.7 (non-reactive), repeat result was 0.69 (non-reactive) the sample was also tested further with the following testing methods/platforms and results: bioscience result was 5.53 s/co (positive) industrial scientific result was 1.406 s/co (cutoff>1, positive), the wantai result was 1.313 s/co (cutoff>1, positive), the elisa result was 1.454, (positive).The customer did not use trust and tppa methodologies, however the customer reported that they may perform further confirmatory testing.Patient information: 53 year-old male, admitted to the hospital for diabetes and poor control of blood sugar, suspected of having metastatic lung cancer.Per the customer the discrepant result(s) were not reported out of the laboratory.There was no reported impact to patient management.

Manufacturer Narrative

D9 date returned to mfg was corrected.

• 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: 18222245
• MDR Text Key: 329207604
• Report Number: 3002809144-2023-00479
• 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,Followup
• Report Date: 02/13/2024

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: 08D06-74
• Device Lot Number: 50281BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 12/05/2023; 12/21/2023; 01/31/2024
• Supplement Dates FDA Received: 12/06/2023; 01/02/2024; 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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, (B)(6) ; ARC I2000SR INST, 03M74-02, (B)(6) ; ARC I2000SR INST, 03M74-02, (B)(6) ; ARC I2000SR INST, 03M74-02, (B)(6) ; ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Age: 53 YR
• Patient Sex: Male