MAUDE Adverse Event Report: ABBOTT LABORATORIES ABBOTT PRISM HIV O PLUS; HIV-1 AND HIV-2 ANTIBODIES

Catalog Number 03D34-48

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.There was no additional patient information provided by the customer.This report is being filed on an international product, prism hiv o plus, list 3d34, that has a similar product distributed in the us, list 3l68.

Event Description

The customer reported (b)(6) prism hiv results on 44 donor samples.The customer provided data for 44 repeat (b)(6) donors, and they were confirmed (b)(6) on alinity.There was no reported impact to donor management.

Manufacturer Narrative

Review of complaint activity determined there was normal complaint activity for the prism hiv o plus reagent, lot 90502li00.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.A retained reagent kit of lot 90502li00 was calibrated, and the calibration met instrument specifications; all control values met control specifications and were in range.A negative human population panel (106 samples) were tested and no false reactive results were obtained.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency was identified for the prism hiv o plus reagent, lot 90502li00.

• Brand Name: ABBOTT PRISM HIV O PLUS
• Type of Device: HIV-1 AND HIV-2 ANTIBODIES
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 8653845
• MDR Text Key: 209393654
• Report Number: 1415939-2019-00034
• Device Sequence Number: 1
• Product Code: MZF
• 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
• Report Date: 07/15/2019

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: 06/24/2019
• Device Catalogue Number: 03D34-48
• Device Lot Number: 90502LI00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/08/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 07/04/2019
• Supplement Dates FDA Received: 07/15/2019
• 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)