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)
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.Additional information suspect medical device; concomitant: abbott esa chagas; list # 08l34-68; lot # a00001300.
Event or Problem Description
The customer reported increase in (b)(6) prism chagas and prism hcv results in (b)(6)2017.Of 14 rr chagas samples 7 were (b)(6).Supplemental/confirmatory testing was performed with ortho chagas (2 (b)(6), 5 not tested); ortho hcv all 7 (b)(6); abbott chagas esa (6 (b)(6), one not tested).There was no reported impact to donor/patient 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 indicates that the initial and repeat reactive rates for the abbott prism chagas lot 68048m500 which is less than the package insert's upper 95% confidence intervals.Labeling claims were met for specificity; there is no product deficiency.A malfunction was not identified.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.

• 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: 6587614
• Report Number: 1415939-2017-00114
• Device Sequence Number: 11007534
• Product Code: MIU
• UDI-Device Identifier: 00380740062941
• UDI-Public: (01)00380740062941(17)170625(10)68048M500
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 06/25/2017
• Device Catalogue Number: 07K35-68
• Device Lot Number: 68048M500
• 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: 05/24/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LOT #72105M500 AND 70080M500,; SERIAL # (B)(4), PRISM HCV, LIST # 06D18-68,