MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM CHAGAS

Catalog Number 07K35-68

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event 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 to (b)(6) 2016, twelve specimens which had been repeat reactive were negative when tested using the ortho method.No specific patient data has been provided.There was no adverse impact to patient management reported.

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 62078m500 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 62078m500, was identified.

Manufacturer Narrative

(b)(4).

• Brand Name: PRISM 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: 6103040
• MDR Text Key: 59904384
• Report Number: 1415939-2016-00110
• Device Sequence Number: 1
• Product Code: MIU
• UDI-Device Identifier: 00380740062941
• UDI-Public: (01)00380740062941(17)170101(10)62078M500
• 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,Followup
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2016
• Device Catalogue Number: 07K35-68
• Device Lot Number: 62078M500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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
• Treatment: LN (B)(4), SN (B)(4); PRISM 6 CHANNEL ANALYZER