MAUDE Adverse Event Report: ABBOTT LABORATORIES ABBOTT PRISM CHAGAS

Catalog Number	07K35-68
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CHAGAS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 9369294
• Report Number: 1415939-2019-00221
• Device Sequence Number: 14169668
• Product Code: MIU
• UDI-Device Identifier: 00380740062941
• UDI-Public: 00380740062941
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2020
• Device Catalogue Number: 07K35-68
• Device Lot Number: 05069M700
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRISM NEXT ANALYZER LIST 06A36-34; PRISM NEXT ANALYZER LIST 06A36-34; SERIAL (B)(6); SERIAL (B)(6)