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 12/12/2023

Event Type  malfunction  

Event Description

The customer observed false nonreactive alinity syphilis tp results for a 57 year old female patient.The following data was provided: initial result = 0.57 s/co, repeat = 0.56 s/co (nonreactive), tppa = positive, rpr = negative, mindray platform = 0.883 (nonreactive) the patient¿s immunoglobin result were normal.No impact to patient management was reported.

Manufacturer Narrative

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 7p60-77 has a similar product distributed in the us, list number 7p60-21/-31.

Event Description

The customer observed false nonreactive alinity syphilis tp results for a 57 year old female patient.The following data was provided: initial result = 0.57 s/co, repeat = 0.56 s/co (nonreactive), tppa = positive, rpr = negative, mindray platform = 0.883 (nonreactive) the patient¿s immunoglobin result were normal.No impact to patient management was reported.Additional information was provided by the customer: the sample was sent for wb testing which generated a negative result, which confirmed the tppa result was a false positive.

Manufacturer Narrative

The complaint investigation for false nonreactive alinity i 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.Additionally, return sample testing was completed.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket search by lot did not identify an increase in complaint activity.Trending review did not identify any related trends.Device history record review did not identify any nonconformances or deviations associated with lot number 55063be01 and complaint issue.In-house sensitivity testing was completed with lot number 55063be00.All specifications were met, and no false non-reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.The return sample was tested with reagent lot 50281be01 and generated a nonreactive result (0.61 s/co).The sample was additionally tested with recomline treponema igm and recomline treponema igg methods which generated negative results (very low intensity).Labeling was reviewed and sufficiently addresses the customer's issue.In this case, no discrepant results were generated during in-house testing.The customer observed a positive tppa result but believes this was a false reactive result as two other methods generated negative results.Based on the investigation the alinity i syphilis tp reagent lot 55063be00 is performing as intended, no systemic issue or deficiency of the alinity i syphilis tp reagent was identified.

• 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: 18382600
• MDR Text Key: 331493868
• Report Number: 3002809144-2023-00500
• 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
• Report Date: 01/22/2024

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: 07P60-77
• Device Lot Number: 55063BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 12/30/2023
• Supplement Dates FDA Received: 01/22/2024
• 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)
• Patient Age: 57 YR
• Patient Sex: Female