MAUDE Adverse Event Report: SUNQUEST INFORMATION SYSTEMS SUNQUEST LABORATORY

Model Number 6.4.1 AND ABOVE

Device Problem Computer Software Problem (1112)

Patient Problem Unspecified Heart Problem (4454)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

193 sites have been notified via product safety notice (psn) and a correction will be available in sunquest laboratory 7.0 and above.There are 0 sites that have already been corrected.No instances of patient harm have been reported as a result of this issue.The root cause of this problem is that the sunquest internal cach¿ coding standards were not met regarding scoping and cleanup of local variables between routines.Sunquest internal standard 'std_401 mcache programing standards' specifies to always use the 'new' command for the variables introduced in the in the subroutines and cach¿ object methods.This is a final report.

Event Description

In sunquest laboratory roll and scroll functions for all online entry (oe, oeh, oehs, oem, oeo) pending tests may get resulted erroneously.For this issue to occur the following criteria and user actions must exist.Criteria for this issue to exist: there must be at least two cups in sequence being processed.The two cups must have at least one test code in common.The tests in the first cup in the sequence contain results from the instrument.At least one calculated test in the second cup in sequence has no result from the instrument.A test that is impacted on the second cup in sequence contains a user defined calculation.Both of these user actions must occur user begins modification to a test in the first cup in sequence with the result but cancels modification.Results are then rejected from the first cup.When the above criteria are met with the rejected result from the first cup, the result on the second cup from the test code in common will be carried over into all remaining pending tests that have a user-defined calculation.This will continue on subsequent cups that meet the criteria until results from a cup are accepted or the function is exited.The error only occurs when a cup contains results for a partial list of tests within the accession (smart not enabled) or container (smart enabled) while others remain pending within online entry.Please note that results filed through automatic filing, windows-based results entry, or lars do not trigger the error.

• Brand Name: SUNQUEST LABORATORY
• Type of Device: LABORATORY
• Manufacturer (Section D): SUNQUEST INFORMATION SYSTEMS; 3300 e. sunrise dr.; tucson 87548
• Manufacturer (Section G): SUNQUEST INFORMATION SYSTEMS; 3300 e. sunrise dr.; tucson AZ 85718
• Manufacturer Contact: chris harmston ; 3300 e. sunrise dr.; tucson, AZ 85718 ; 7206603377
• MDR Report Key: 11616238
• MDR Text Key: 249073720
• Report Number: 2029302-2020-00001
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 11/25/2020

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
• Device Operator: Other
• Device Model Number: 6.4.1 AND ABOVE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 04/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1