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 Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

The account generated false repeatedly reactive prism chagas results on 20 donors that tested esa chagas negative since (b)(6) 2016.Additionally, 5 donors were prism chagas were repeatedly reactive but no confirmatory testing was available since january 2016.No impact to patient management was reported.No specific donor information was available.

Manufacturer Narrative

Evaluation of complaint data for the products and likely cause lot identified normal complaint activity.Additionally, review of the device history records for the likely cause lot did not reveal any issues related to the customer's observations.Label reviews were also performed and found them to adequately address the customer's issue.Finally, review of the prism metrics field data indicates that the initial and repeat reactive rates for the abbott prism chagas products are less than the package insert upper 95% confidence intervals.Therefore, the lots are meeting labeling claims for clinical specificity.There is no malfunction or product deficiency.The abbott prism chagas products are performing acceptably.

• Brand Name: PRISM CHAGAS
• Type of Device: CHAGAS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• 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: 6118950
• MDR Text Key: 60660043
• Report Number: 1415939-2016-00115
• Device Sequence Number: 1
• Product Code: MIU
• UDI-Device Identifier: 00380740062941
• UDI-Public: (01)00380740062941(17)170312(10)64065M500
• 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: 01/17/2017

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: 01/01/2017
• Device Catalogue Number: 07K35-68
• Device Lot Number: 64065M500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PRISM LIST 06A36-04, SERIAL (B)(4)