MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC PRISM NEXT ANALYZER; AUTOMATED IMMUNOASSAY ANALYZER

Catalog Number 06A36-11

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported falsely repeat reactive prism anti-hcv results on multiple donors.Initial and repeat reactive rates for the anti-hcv assay increased the week ending 15jun2019 and continued through the week ending 22jun2019.Historically, hcv repeat reactive rates run 0.04% of total donors tested, with more than 50% confirming by supplemental dhcv testing.During the two weeks named above, hcv repeat reactive rates were 0.07% of total donors tested, with only 30% confirming.No impact to donor management was reported.

Manufacturer Narrative

The evaluation of complaint data for increased initial and repeat reactive rates while processing abbott prism hcv with prism reaction trays, (list number 05a07-01, likely cause lot# 03018m700), identified normal complaint activity.No customer returns were available for evaluation.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 lots.This review did not identify any non-conformances, potential non-conformances or deviations.A review of overall customer field data was performed regarding initial reactive rate (irr), repeat reactive rate (rrr) and specificity for prism hcv with prism tray lot 03018m700.The irr, the rrr and the specificity of the lot is within package insert specifications.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the prism tray lot 03018m700.

• Brand Name: PRISM NEXT ANALYZER
• Type of Device: AUTOMATED IMMUNOASSAY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8776958
• MDR Text Key: 150588529
• Report Number: 1628664-2019-00481
• Device Sequence Number: 1
• Product Code: MZA
• UDI-Device Identifier: 00380740008420
• UDI-Public: 00380740008420
• 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: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06A36-11
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LOT# 02036N100; PRISM HCV, LIST # 06D18-68,; LOT# 02036N100; PRISM HCV, LIST # 06D18-68,