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 01/09/2015

Event Type  malfunction  

Event Description

The account stated the donor sample id (b)(6) generated false reactive prism chagas results (15.39, 14.42, 12.83 s/co) but tested ortho chagas 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.

Manufacturer Narrative

Udi: (b)(4).Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided the customer had a dual reactive chagas and (b)(6) sample when using abbott prism chagas, list number 7k35, lot 39515m500 and abbott (b)(6), list number 6d18, lot 45055m500.Refer to manufacturer report # 1415939-2015-00015 for (b)(6).Evaluation of complaint data for the products and reagent lots used by the customer identified normal complaint activity.Additionally, review of the device history records for the reagent lots 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, review of the prism metrics field data indicates that the initial and repeat reactive rates for the abbott (b)(6) and abbott prism chagas products are less than the package insert upper 95% confidence intervals.As a result, there is not enough information to reasonably suggest a malfunction (within performance claims).This investigation indicates that the product is performing as expected; there is no deficiency.

• 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: 4779033
• MDR Text Key: 5804228
• Report Number: 1415939-2015-00014
• 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: 03/03/2015
• Device Catalogue Number: 07K35-68
• Device Lot Number: 39515M500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2015
• Initial Date FDA Received: 05/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISM ANALYZER LIST 06A36-04; SERIAL (B)(4)