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

Model Number PH 9

Device Problem Incorrect Software Programming Calculations (1495)

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

Event Date 07/17/2015

Event Type  malfunction  

Manufacturer Narrative

Test configuration was reviewed and an issue has been found on executing the rule that computes the final result.If the first result is (b)(4) the software re-triggers the test in duplicate.Then the 2/3 rule is applied.The error is in the test configuration of the algorithm of the 2/3 rule when the initial result is changed from (b)(6).Rules are created by the customer during the implementation.There are no reports of adverse health consequences due to this issue.

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.The (b)(6) public health lab notified abbott informatics of an issue with the script code used to generate the hl7 lab result message due to the 2 of 3 rule for the (b)(6) testing protocol.The rule is the following: (b)(6).During the approval process, it was discovered that the initial result should have been (b)(6).The supervisor sent the sample back for retest, and resulted as (b)(6).The sample now has (b)(6) result line items in the results table, but the hl7 lab result message contained a repeatedly (b)(6) lab result.The public health clinic called the patient into the clinic, and provided the patient with a paper lab result report that stated the patient was (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: dimitris demirtzoglou ; 4000 hollywood blvd; suite 333 south; hollywood, FL 33021 ; 9544161651
• MDR Report Key: 5817179
• MDR Text Key: 51232929
• Report Number: 3006130047-2016-00007
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2016

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 9
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/17/2015
• Initial Date FDA Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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