MAUDE Adverse Event Report: ABBOTT LABORATORIES ABBOTT PRISM HCV; ANTI-HCV

Catalog Number 06A52-48

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, list number (b)(4) manufactured in (b)(6), that has a similar product distributed in the us, list number (b)(4), manufactured in (b)(6).

Event Description

The customer reported false reactive prism hcv results on 46 donor samples.The customer provided data for 46 repeat reactive donors, and they were confirmed negative on alinity.There was no reported impact to donor management.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data, and a review of labeling.No adverse trend was identified for the customer's issue.No return patient sample was available.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within expected limits.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: ABBOTT PRISM HCV
• Type of Device: ANTI-HCV
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 8653709
• MDR Text Key: 146489752
• Report Number: 1415939-2019-00033
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

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: 09/22/2019
• Device Catalogue Number: 06A52-48
• Device Lot Number: 96276LI00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/18/2019
• 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)