MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. GEM PREMIER 5000; CLINICAL CHEMISTRY INSTRUMENT

Model Number	2262
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/27/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The investigation is currently ongoing; a follow up report will be submitted.
Event or Problem Description
Customer reported that connection with lis was in an unstable state (connections/disconnections).The gem premier 5000 connections and transfers to gwp were affected.During the various disconnections, a 10-year-old patient was in absolute emergency.This patient needed to have a gasometry performed to adapt his treatment.All instruments in the emergency department (outsourced biology) did not work and were unable to carry out the requested examination, the patient was admitted on (b)(6) 2023 at 3:19.Customer reported that blood gas results were provided at 5:02pm.The manufacturer was informed on june 7th 2023 that the patient died on (b)(6) 2023, cause of death was not shared.
Additional Manufacturer Narrative
On february 27, 2023, a werfen representative contacted our it department about problems accessing the gemweb plus (gwp) with the gem premier 5000 analyzers, which were reporting disconnections.Customer investigations noted that there were disconnect/reconnections, an unstable state, with their lis.The hospital's various departments went into stand-alone mode.Il (werfen) investigation found that a logical disk was almost full, which could have had an impact on the operation of gemweb plus.Werfen it department provided a procedure for deleting temporary disk trace files.Once the procedure had been applied by the hospital's data center manager and the gemweb plus machine had been restarted, connections with the gem premier were restored and the gemweb plus interface was once again accessible.To resolve the issue gemweb plus debug mode needed to be switched from expert mode (which consumes a lot of disk space and is used for investigations) to standard mode.This customer has switched to standard mode.This customer issue was resolved with these actions.The patient was receiving appropriate medical treatment throughout the software downtime and the patient unfortunately died the next day, over 24 hours from admission.

• Brand Name: GEM PREMIER 5000
• Common Device Name: CLINICAL CHEMISTRY INSTRUMENT
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730
• Manufacturer Contact: anuja khan ; 180 hartwell road; bedford, MA 01730
• MDR Report Key: 17239800
• Report Number: 1217183-2023-00003
• Device Sequence Number: 14661182
• Product Code: CHL
• UDI-Device Identifier: 08426950870227
• UDI-Public: 08426950870227
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K203790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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: 2262
• Device Catalogue Number: 00024019255
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 10 YR
• Patient Sex: Unknown