MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM CHAGAS

Catalog Number 07K35-68

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2015

Event Type  malfunction  

Event Description

The account generated false reactive prism chagas results (1.00, 1.07, 1.26 s/co) on a donor who tested ortho chagas eia confirmation negative.No impact to patient management was reported.No specific donor information was provided.

Manufacturer Narrative

(b)(4).An evaluation is in process.A followup report will be submitted when the evaluation is complete.Evaluation in process.

Manufacturer Narrative

Udi: (b)(4).Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided.The evaluation of complaint data for the product and likely cause lot identified normal complaint activity.Additionally, a review of the device history record for the likely cause lot did not reveal any issues related to the customer's observations.A label review was also performed and found labeling to adequately address the customer's issue.Finally, a review of the prism metrics field data indicates that the initial and repeat reactive rates for the abbott prism chagas product are less than the package insert upper 95% confidence intervals.Based on this investigation, the abbott prism chagas product is performing as expected.

• Brand Name: PRISM CHAGAS
• Type of Device: CHAGAS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 350
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 350
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 4779724
• MDR Text Key: 5819309
• Report Number: 1415939-2015-00016
• Device Sequence Number: 1
• Product Code: MIU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: 07K35-68
• Device Lot Number: 41277M500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 05/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISM LIST 06A36-04; SERIAL (B)(4)