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 Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer reported a (b)(6) alinity i syphilis tp result on one patient.Results provided: (b)(6), architect = (b)(6), previous (b)(6) antibody test was (b)(6) along with a (b)(6) test, elisa test is (b)(6).No impact to patient management was reported.

Manufacturer Narrative

After further evaluation, the suspect medical device lot# was changed from 11057be00 list # 07p60-32 to lot# 11057be01, list # 07p60-77, manufacturing site remains the same.Section d4 has been updated to reflect this information.

Manufacturer Narrative

The evaluation of complaint data for the product and likely cause alinity i syphilis tp reagent lot 11057be01 identified normal complaint activity.There are no trends for the product related to patient results.No customer returns were available for evaluation.A retained kit of reagent lot 11057be01 was tested for sensitivity and the data shows that the sensitivity performance of lot 11057be01 is not negatively impacted.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.The performance of the likely cause lot was investigated by completing a review for non-conformances, potential non-conformances and deviations related to the likely cause lot.This review did not identify any non-conformances, potential non-conformances or deviations.A review of labeling concluded that the issue is sufficiently addressed.No product deficiency 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
• MDR Report Key: 10792024
• MDR Text Key: 214800735
• Report Number: 3002809144-2020-01088
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• PMA/PMN Number: K153730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2020
• Device Catalogue Number: 07P60-77
• Device Lot Number: 11057BE01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/06/2021
• 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); ALNTY I PROCESSING MODU, 03R65-01, AI03097