MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. MINIMED QUICK-SET; UNO QUICK-SET 60/9 SC1 MECA

Model Number	MMT-943A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	04/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occured in the united arab emirates.On (b)(6) 2025, the patient had low blood sugar of 60 mg/dl.They ate carbs to help, but still needed medical help.They went to the emergency room.The patient was using an insulin pump before this happened.They stayed in the hospital for less than a day.No further information available.
Additional Manufacturer Narrative
E1: patient city: (b)(6), patient country: united arab emirates.
Additional Manufacturer Narrative
Additional information - this mdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions h11: investigation summary: the information in this complaint (b)(4) has been evaluated for the malfunction code no malfunction based on complaint information.The batch 6007528 in question was manufactured at the reynosa site.Complaint investigation results: the reference samples cannot be tested because there was no specific malfunction to investigate.Device history record (dhr) review: the lot 6007528 was manufactured according to the work instruction (wi) version 72 manufactured in the line inset 8, on 10/jun/2024, with a total of (b)(4) units.Review of the dhr showed that all relevant tests required during the related processes had been fulfilled and met the requirements.No deviation was identified, nor maintenance events were recorded related to complaint code.Trending: a query was run in database on 13-may-2025 against malfunction code no malfunction based on complaint information, harm code asymptomatic elevated blood glucose no change to regular treatment regime and lot 6007528 and other 2 complaints have been registered in database for the same lot number, harm code and malfunction code.Conclusion summary of complaint investigation: as a result of the following: no non-conformance (nc) raised during production related to complaint code, no trend identified for the lot in question and malfunction code, no further actions are required.This complaint will not require further root cause investigation nor capa plan.Therefore, this issue will be monitored through the post market surveillance activities.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: MINIMED QUICK-SET
• Common Device Name: UNO QUICK-SET 60/9 SC1 MECA
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; ave. fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p., 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 21959170
• Report Number: 3003442380-2025-07785
• Device Sequence Number: 7272792
• Product Code: FPA
• UDI-Device Identifier: 05705244020030
• UDI-Public: 05705244020030
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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?: Yes
• Device Model Number: MMT-943A
• Device Lot Number: 6007528
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown