MAUDE Adverse Event Report: ABBOTT LABORATORIES 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.(b)(6).

Event 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.

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
• Type of Device: CHAGAS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 8344022
• MDR Text Key: 139451669
• Report Number: 1415939-2019-00010
• 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: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2019
• Device Catalogue Number: 07K35-68
• Device Lot Number: 89045M500
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISM 6 CHANNEL ANALYZER, LN 06A36-04; PRISM 6 CHANNEL ANALYZER, LN 06A36-04; SERIAL (B)(4); SERIAL (B)(4)