MAUDE Adverse Event Report: ABBOTT LABORATORIES ABBOTT PRISM HTLV-I/HTLV-II; HTLV-I/ HTLV-II ANTIBODIES

Catalog Number 06A53-48

Device Problem High Test Results (2457)

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

Event Date 05/08/2019

Event Type  malfunction  

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 6a53 that has a similar product distributed in the us, list number 6e50.

Event Description

The customer reported false reactive prism htlv-i/ii results on 7 donor samples.The customer provided data for 7 repeat reactive donors, and they were confirmed negative on alinity.There was no reported impact to donor management.

Manufacturer Narrative

On may 30, 2019, the lot number of the suspect medical device was provided and updated from unknown to 94091li00.

Manufacturer Narrative

Review of complaint activity determined there was normal complaint activity for the prism htlv-i/htlv-ii reagent, lot 94091li00.Tracking and trending report review determined there are no related adverse or non- statistical trends.The performance of the likely cause lot was investigated, and no issues were identified.Using customer field data, the initial reactive rate (irr), repeat reactive rate (rrr), and specificity for lot 94091li00 were evaluated.The irr, rrr, and specificity were all determined to be within package insert specifications.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency was identified for the prism htlv-i/htlv-ii reagent, lot 94091li00.

• Brand Name: ABBOTT PRISM HTLV-I/HTLV-II
• Type of Device: HTLV-I/ HTLV-II ANTIBODIES
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 8654018
• MDR Text Key: 146510728
• Report Number: 1415939-2019-00035
• Device Sequence Number: 1
• Product Code: MTP
• Combination Product (y/n): N
• 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: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2020
• Device Catalogue Number: 06A53-48
• Device Lot Number: 94091LI00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISM, LIST 06A36-04, SERIAL (B)(4); PRISM, LIST 06A36-04, SERIAL (B)(4); PRISM, LIST 06A36-04, SERIAL (B)(4); PRISM, LIST 06A36-04, SERIAL (B)(4)