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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: CHAGAS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 6118950
• Report Number: 1415939-2016-00115
• Device Sequence Number: 13640232
• Product Code: MIU
• UDI-Device Identifier: 00380740062941
• UDI-Public: (01)00380740062941(17)170312(10)64065M500
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2017
• Device Catalogue Number: 07K35-68
• Device Lot Number: 64065M500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2016
• Supplement Report FDA Received Date: 01/17/2017
• 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 LIST 06A36-04, SERIAL (B)(4)