MAUDE Adverse Event Report: EITAN MEDICAL LTD. SAPPHIRE M.T INFUSION PUMP - FRENCH; INFUSION PUMP

Catalog Number	15031-000-0002
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	03/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Eitan medical has conducted attempts to receive the event log of pump, as well as the pump itself, for investigation.To date, only the event log has been received and is currently under investigation.Event log investigation findings will be provided in the follow up report.This reported event occurred outside of the us on a device that is similar to the one marketed in the us and for which there is no data in gudid.Device's premarket submission number: k192860.
Event or Problem Description
This complaint was reported by a customer from usa.A delivery issue was reported.Human harm was reported as hypoglycemia.It was reported that the patient was hospitalized as a result of this event.It was reported that the patient is "ok now after hospitalization".

• Brand Name: SAPPHIRE M.T INFUSION PUMP - FRENCH
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): EITAN MEDICAL LTD.; yad harutzim st. 29; netanya, 42505 29; IS 4250529
• Manufacturer (Section G): EITAN MEDICAL LTD.; yad harutzim st. 29; netanya, 42505 29; IS 4250529
• Manufacturer Contact: guy mlechkowich ; yad harutzim st. 29; netanya, 42505-29 ; IS 4250529
• MDR Report Key: 24740046
• Report Number: 3010293992-2026-00027
• Device Sequence Number: 8869212
• Product Code: FRN
• UDI-Device Identifier: 7290109150710
• UDI-Public: (01)7290109150710(11)230131
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K192860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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: Other
• Device Catalogue Number: 15031-000-0002
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2023
• 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: Hospitalization
• Patient Sex: Unknown