MAUDE Adverse Event Report: BECKMAN COULTER ACCESS ACCUTNI+3 REAGENT; ANALYZER, CHEMISTRY

Model Number A98143

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Chest Pain (1776)

Event Date 03/19/2018

Event Type  Injury  

Event Description

Pt presented to the ed with epigastric and chest pain that has intensified over the last five days.Pt had troponin labs drawn, and samples were processed on beckman coulter dxi utilizing accutni+3 reagent.Troponin levels measured 2.67 ((b)(6) at 2305) that trended down to 2.59 ((b)(6) at 0450) and 2.49 ((b)(6) at 0555).During this time, point-of-care troponin levels remained within normal levels.Pt was taken to cath lab and did not have any discernable lesions per dr travis love in cardiology.Specimen collected at 0450 on (b)(6) was sent to outside lab and tested on a bitros analyzer.Result was <0.01.

• Brand Name: ACCESS ACCUTNI+3 REAGENT
• Type of Device: ANALYZER, CHEMISTRY
• Manufacturer (Section D): BECKMAN COULTER; brea CA
• MDR Report Key: 7373250
• MDR Text Key: 103691616
• Report Number: MW5076159
• Device Sequence Number: 0
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: A98143
• Device Lot Number: 724139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 44 YR
• Patient Weight: 95