MAUDE Adverse Event Report: MEDICAL INFORMATION TECHNOLOGY, INC. EXPANSE LABORATORY/MICROBIOLOGY

Model Number	EXPANSE RELEASE 2.2
Medical Device Problem Code	Failure to Transmit Record (1521)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient event was not caused by a software malfunction within medical information technology, inc's class i expanse laboratory/microbiology product.Upon being notified of the adverse event on october 23, 2024, medical information technology, inc,'s client support team reviewed the customer's configuration and confirmed a report containing the initial urine culture results from (b)(6) 2024 was not sent to the ordering provider.The customer had configured their system to exclude telecommunications to the location where the patient's specimen was received from.This prevented the report from faxing.Further investigation by medical information technology, inc.Determined that the customer, on their own, had corrected their configuration on (b)(6) 2024 to include the location where the patient's specimen was received from.This was two days before the adverse event was reported to medical information technology, inc.On october, 23 2024.
Event or Problem Description
On october 23, 2024 a customer reported an adverse event where a patient's report was not faxed from the laboratory to the ordering provider after microbiology culture results were verified.Concerns were raised about the patient's admission to the hospital due to sepsis.The customer asserted that the admission could have been avoided if the provider had received the report and administered an antibiotic effective in treating the patient's escherichia coli (e.Coli) infection.

• Brand Name: EXPANSE LABORATORY/MICROBIOLOGY
• Common Device Name: EXPANSE LABORATORY/MICROBIOLOGY
• Manufacturer (Section D): MEDICAL INFORMATION TECHNOLOGY, INC.; 7 blue hill river rd; canton MA 02021
• Manufacturer (Section G): MEDICAL INFORMATION TECHNOLOGY, INC.; 7 blue hill river rd; canton MA 02021
• Manufacturer Contact: mike hochella ; 7 blue hill river rd.; canton, MA 02021 ; 7818213000
• MDR Report Key: 20706009
• Report Number: 3009404844-2024-00001
• Device Sequence Number: 13162827
• Product Code: JQP
• UDI-Device Identifier: 00863529000155
• UDI-Public: 00863529000155
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 11/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EXPANSE RELEASE 2.2
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 35 YR
• Patient Sex: Unknown