MAUDE Adverse Event Report: ABBOTT LABORATORIES ABBOTT ESA CHAGAS

Catalog Number	08L34-68
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot/serial number was not provided by the customer; therefore, only a partial udi is known.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a blood donor who tested reactive for prism anti-t.Cruzi and was esa chagas positive.The sample was sent for follow-up testing by the cdc for t.Cruzi ab eia and t.Cruzi ab ib (tesa) which were both negative.There was no reported impact to donor management.There was no additional donor information provided.
Additional Manufacturer Narrative
Evaluation of complaint data for the list number 8l34 (lot was unknown) identified normal complaint activity and no trends were identified for the abbott esa chagas assay.A review of the manufacturing documentation did not identify any issues associated with the customer observation.A review of the package insert showed that within a study 99.1% of us blood donors were negative with a 95% confidence interval of 97.4% to 99.8%.No sample was false positive within this study, however, it also states, that false reactive test results can be expected with any test kit.Also a study was performed by testing us blood donor samples that were repeat reactive with the prism chagas assay.Some of the samples were also positive on the esa chagas assay, but nonreactive on t cruzi ripa.Based on the data generated during this investigation, the performance of the abbott esa chagas assay is within specifications.A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.However, a systemic issue and/or product deficiency was not identified.

• Brand Name: ABBOTT ESA CHAGAS
• Common Device Name: CHAGAS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 6598065
• Report Number: 1415939-2017-00119
• Device Sequence Number: 10915802
• Product Code: MIU
• UDI-Device Identifier: 00380740089535
• UDI-Public: 00380740089535
• 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): 06/08/2017

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 Catalogue Number: 08L34-68
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 06/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1