MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM CHAGAS

Catalog Number	07K35-68
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2016
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.An evaluation is in-process.
Event or Problem Description
The customer indicated an increase in reactive results has been generated while using the prism chagas assay on the prism 6 channel analyzer.During the timeframe of (b)(6) 2016, twelve specimens which had been repeat reactive were negative when tested using the ortho method.Specifically the customer indicated that a false positive result was generated on (b)(6) 2016 using lot 61004m500.No specific patient data has been provided.There was no adverse impact to patient management reported.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, in-house testing, a device history review, a search for similar complaints, and a review of labeling.Return material was not available from the customer.A specificity testing protocol was executed using lot 61004m500 and met acceptance criteria and determined the reagent is performing acceptably.The device history review did not identify any non-conformances or deviations related to the customer's observations.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the prism chagas reagent, list number 07k35-68, lot number 61004m500, was identified.
Additional Manufacturer Narrative
(b)(4).

• 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: 6103039
• Report Number: 1415939-2016-00111
• Device Sequence Number: 10836475
• Product Code: MIU
• UDI-Device Identifier: 00380740062941
• UDI-Public: (01)00380740062941(17)161125(10)61004M500
• 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,Followup
• Report Date (Section B): 05/10/2017

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: 11/25/2016
• Device Catalogue Number: 07K35-68
• Device Lot Number: 61004M500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/02/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/15/2016
• Supplement Report FDA Received Date: 12/21/2016; 05/10/2017
• 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: LN 06A36-04, SN (B)(4) ; PRISM 6 CHANNEL ANALYZER