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

Model Number PH 11.0

Device Problem Programming Issue (3014)

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

Event Date 03/14/2016

Event Type  malfunction  

Manufacturer Narrative

Abbott informatics evaluated and confirmed the issue was reproducible.The system is looking at the default panel configuration instead of validating the tests that are associated with the sample.An investigation is still underway.A follow up report will be submitted when the investigation is completed.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.A customer notified abbott informatics that results of non-default tests are being deleted.If a sample has a panel with both default and non-default tests, and a second panel is added the results from the first panel's non-default tests are erroneously deleted.

Manufacturer Narrative

The report date in the initial report ought to have been 06/21/2016, the date the mdr was submitted.

Event Description

Manufacturer Narrative

The investigation regarding this issue confirmed that it was a design deficiency.Furthermore, the risk assessment for this issue indicated that the risk of harm is improbable.A field action will be conducted in the near future to correct the issue in all impacted systems.

• 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: 5739902
• MDR Text Key: 48817467
• Report Number: 3006130047-2016-00005
• 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,Followup,Followup
• Report Date: 08/09/2016

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: Medical Technologist
• Device Model Number: PH 11.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/16/2016
• Initial Date FDA Received: 06/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/22/2016; 08/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2014
• 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