MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM CHAGAS

Catalog Number	07K35-68
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
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 lots identified normal complaint activity.A review of the manufacturing documentation did not identify any issues associated with the customer observation.Labeling was reviewed and found to adequately address the issue.A review of the prism metrics field data for the abbott prism chagas lot 68048m500 was performed for specificity.A total of 443,845 samples were tested across multiple customer sites and the initial and repeat (b)(4), respectively, which are less than the prism chagas package insert upper 95% confidence intervals of 0.28% and 0.23%.Therefore, the lot is meeting labeling claims for clinical specificity.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: PRISM CHAGAS
• Common Device Name: CHAGAS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 6594069
• Report Number: 1415939-2017-00117
• Device Sequence Number: 395510
• Product Code: MIU
• UDI-Device Identifier: 00380740062941
• UDI-Public: (01)00380740062941(17)170505(10)66035M500
• 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): 06/07/2017

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: 05/05/2017
• Device Catalogue Number: 07K35-68
• Device Lot Number: 66035M500
• Was Device Available for Evaluation?: Yes
• 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: 05/26/2017
• Supplement Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1