MAUDE Adverse Event Report: ABBOTT INFORMATICS CORPORATION STARLIMS PUBLIC HEALTH SOLUTION; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number PH 10.08

Device Problem Application Program Problem (2880)

Patient Problem No Code Available (3191)

Event Date 04/28/2017

Event Type  malfunction  

Manufacturer Narrative

During the investigation it was discovered that the customer altered the crystal report template that caused the results to be sorted in the wrong order which then caused the algorithm to incorrectly show the final result on the report.It was noted that the database administrator at the lab ran a maintenance job that updated the database engines optimization plan which caused the sort order to change exploiting the bug in the report.There was no product malfunction.We have been in constant communication with the lab and there are no reports of adverse health consequences due to this issue at this time.

Event Description

Starlims public health solution is intended for use by public health laboratory professionals and it is designed to receive and process samples from clinical, culture, environmental, food and other ad-hoc or planned sample submissions.The application provides single and multiple site facilities the ability to store, retrieve, process and manage the data associated with specimen testing including but not limited to patient demographics, tests ordered, test results, test result interpretation, quality control results, and result codes (flags) that may be associated with the specimen from its entry into the laboratory workflow until the report (including patient report) is generated and released.Sample information may also be retained and used for epidemiological studies or submission to adjunct agencies such as governmental public health organizations.When the software is deployed, configurable settings are programmed based on the customer preferences.For instance, each laboratory enters their specific population based reference ranges that are used to evaluate if a patient's test results are normal, below or above the reference range and require further action such as repeat testing.Each laboratory enters their specific reporting rules for reporting samples through various electronic interfaces.A customer notified abbott informatics that (b)(6) reports are showing incorrect results for 115 patients during the time period of (b)(6) 2017.Some patients were treated although they were (b)(6) and others were not treated even though they were (b)(6).

• Brand Name: STARLIMS PUBLIC HEALTH SOLUTION
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT INFORMATICS CORPORATION; 4000 hollywood blvd; suite 333 south; hollywood FL 33021
• Manufacturer (Section G): ABBOTT INFORMATICS CORPORATION; 4000 hollywood blvd; suite 333 south; hollywood FL 33021
• Manufacturer Contact: linda ryan ; 4000 hollywood blvd.; suite 333 south; hollywood, FL 33021 ; 9544161639
• MDR Report Key: 6593865
• MDR Text Key: 76245714
• Report Number: 3006130047-2017-00002
• 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: Other
• Type of Report: Initial
• Report Date: 05/26/2017

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
• Device Operator: No Information
• Device Model Number: PH 10.08
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2017
• Initial Date FDA Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2012
• 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