MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I HAVAB-IGG REAGENT KIT; HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)

Catalog Number 08P26-22

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product list 8p26, that has a similar us product distributed in the us, list 8p27.An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

The account observed false reactive alinity i havab igg values between 1 to 2 s/co on samples that repeat reactive but when a new sample is obtained a negative result is generated.The patients are hiv positive that come to the lab for routine vaccination.No specific patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

The complaint evaluation 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 testing of in house retained kits with the complaint lot number.The ticket search by lot indicates that the reagent lot performs as expected for this product.Trending review determined no adverse trend for the issue for the product.Labeling review concludes that the issue is adequately addressed.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.Results of in house testing of a retained kit showed that, all specifications were met and no false reactive results were obtained, indicating that the specificity performance is not negatively impacted.Based on the evaluation, no systemic issue or product deficiency with the alinity i havab igg reagent lot was identified in the complaint.

• Brand Name: ALINITY I HAVAB-IGG REAGENT KIT
• Type of Device: HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11071926
• MDR Text Key: 223608187
• Report Number: 3002809144-2020-01208
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• PMA/PMN Number: K113704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2021
• Device Catalogue Number: 08P26-22
• Device Lot Number: 16126BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI01890; ALNTY I PROCESSING MODU, 03R65-01, AI01890; ALNTY I PROCESSING MODU, 03R65-01, AI01890