MAUDE Adverse Event Report: ABBOTT LABORATORIES ABBOTT ESA CHAGAS

Catalog Number 08L34-68

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2017

Event Type  malfunction  

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 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.

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
• 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: 6598065
• MDR Text Key: 76283643
• Report Number: 1415939-2017-00119
• Device Sequence Number: 1
• Product Code: MIU
• UDI-Device Identifier: 00380740089535
• UDI-Public: 00380740089535
• 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: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08L34-68
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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