MAUDE Adverse Event Report: ABBOTT LABORATORIES 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.(b)(6).
Event or Problem Description
The customer reported a false repeat reactive abbott prism chagas results.Sample id (b)(6) : (b)(6) year old male, prism chagas repeat reactive and negative on chagas ortho summit assay sample id (b)(6): (b)(6) year old male, prism chagas repeat reactive and negative on chagas ortho summit assay sample id (b)(6): (b)(6) year old male, prism chagas repeat reactive and negative on chagas ortho summit assay no impact to patient/donor management was reported.
Additional Manufacturer Narrative
Review of complaint activity did not identify any adverse trends for the prism chagas assay.Normal complaint activity was identified for the likely cause lot.Using field data the performance of lot 89045m500 was evaluated.The initial reactive and repeat reactive rates of the complaint lot were within package insert specifications.Additionally, assuming a zero prevalence of t cruzi infection for the samples tested the specificity of lot 89045m500 would be within package insert specifications.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the prism chagas assay was identified.

• Brand Name: PRISM CHAGAS
• Common Device Name: CHAGAS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 8344022
• Report Number: 1415939-2019-00010
• Device Sequence Number: 1915847
• 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): 04/05/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2019
• Device Catalogue Number: 07K35-68
• Device Lot Number: 89045M500
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 04/05/2019
• 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 6 CHANNEL ANALYZER, LN 06A36-04; PRISM 6 CHANNEL ANALYZER, LN 06A36-04; SERIAL (B)(4); SERIAL (B)(4)