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

Catalog Number 07P60-77

Device Problem False Negative Result (1225)

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

Event Date 10/29/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 7p60-77 and there is a similar product distributed in the us, list number 7p60 -21 / 31.E1 phone: complete phone number is (b)(6) all available patient information was included.Additional patient details are not available.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 alinity i syphilis tp and provided the following data for 1 male dermatology patient: customer reference range < 1.0 s/co is non-reactive initial result was 0.28 (non-reactive).The roche result was 1.44 (positive), and the colloidal gold and tppa results were also positive.The sample was tested using elisa and autobio platforms, and both results were negative.The customer is not sure which results are correct and stated they will consider further testing.Per the customer, the discrepant result was not reported out to the patient¿s medical provider.There was no reported impact to patient management.

Manufacturer Narrative

Section d9 - date returned to mfg was corrected.

Event Description

The customer reported false non-reactive alinity i syphilis tp and provided the following data for 1 male dermatology patient: customer reference range < 1.0 s/co is non-reactive initial result was 0.28 (non-reactive).The roche result was 1.44 (positive), and the colloidal gold and tppa results were also positive.The sample was tested using elisa and autobio platforms, and both results were negative.The customer is not sure which results are correct and stated they will consider further testing.Per the customer, the discrepant result was not reported out to the patient¿s medical provider.There was no reported impact to patient management.

Event Description

The customer reported false non-reactive alinity i syphilis tp and provided the following data for 1 male dermatology patient: customer reference range < 1.0 s/co is non-reactive.Initial result was 0.28 (non-reactive).The roche result was 1.44 (positive), and the colloidal gold and tppa results were also positive.The sample was tested using elisa and autobio platforms, and both results were negative.The customer is not sure which results are correct and stated they will consider further testing.Per the customer, the discrepant result was not reported out to the patient¿s medical provider.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.A returned sample was provided and testing was performed with the returned sample.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 non-conformances or deviations for the complaint lot and customer reported issue.The ticket search by lot did not identify an increase in complaint activity.Review of ticket and trending concluded that there was no identified trend regarding commonalities for lot number and customer issue.In-house testing was conducted on lot 55063be00, which contains the same bulk material as lot 55063be01.Testing found that all specifications were met, no false non-reactive results were obtained, and concluded the lot generates the expected results.Returned patient sample testing was conducted and generated the following results: alinity i syphilis tp (lot 50281be01) result was 0.29 s/co (non-reactive), recomline treponema igg result was negative (no reaction), recomline treponema igm result was negative (tmpa: low intensity).Return sample testing concluded that a non-reactive result was generated for the return sample with alinity i syphilis tp lot 50281be01 in conjunction with no discrepant results that were generated (recomline treponema igm and igg results).Labeling was reviewed and was found to address the customer reported issue.Based on the investigation, no systemic issue or deficiency was identified for the alinity i syphilis tp reagent, lot number 55063be01.

• Brand Name: ALINITY I 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: 18151527
• MDR Text Key: 328636300
• Report Number: 3002809144-2023-00469
• 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: 02/14/2024

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 Expiration Date: 07/27/2024
• Device Catalogue Number: 07P60-77
• Device Lot Number: 55063BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 01/30/2024; 02/13/2024
• Supplement Dates FDA Received: 01/30/2024; 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Sex: Male