MAUDE Adverse Event Report: ABBOTT LABORATORIES ABBOTT PRISM CHAGAS

Catalog Number 07K35-68

Device Problem False Positive Result (1227)

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.All available patient information was included.Additional patient details are not available.

Event Description

The customer reported an increase in false repeat reactive prism chagas results on multiple donors that did not confirm by esa chagas confirmatory testing.No impact to donor management was reported.

Manufacturer Narrative

The evaluation of complaint data for the product and likely cause abbott prism chagas lot 05069m700 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 lot.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) and repeat reactive rate (rrr) for lot 05069m700.The irr and the rrr of the lot is within package insert specifications.A review of labeling concluded that the issue is sufficiently addressed.No product deficiency was identified.

• Brand Name: ABBOTT PRISM CHAGAS
• Type of Device: CHAGAS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 9369294
• MDR Text Key: 220531160
• Report Number: 1415939-2019-00221
• Device Sequence Number: 1
• Product Code: MIU
• UDI-Device Identifier: 00380740062941
• UDI-Public: 00380740062941
• 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: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2020
• Device Catalogue Number: 07K35-68
• Device Lot Number: 05069M700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISM NEXT ANALYZER LIST 06A36-34; PRISM NEXT ANALYZER LIST 06A36-34; SERIAL (B)(6); SERIAL (B)(6)