FDA Adverse Event Injury Summary report: N

MINIMED 670G INSULIN PUMP

MDR report key: 10307491 · Received July 21, 2020

Report

Report Number
MW5095645
Event Type
Injury
Date Received
July 21, 2020
Date of Event
July 17, 2020
Report Date
July 17, 2020
Manufacturer
MEDTRONIC MINIMED
Product Code
OZP
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
LA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I USE A MEDTRONIC 670G INSULIN PUMP. I RECEIVED MULTIPLE ERRORS, ERROR NO 37, "DELIVERY STOPPED. SETTINGS UNCHANGED. PUMP RESTART NEEDED, SELECT OK TO RESTART. I WAS ADVISED, MY A MEDTRONIC REPRESENTATIVE THAT THE ERROR COULD NOT BE CORRECTED AND A NEW PUMP WOULD BE ISSUED BUT COULD NOT BE DELIVERED OVERNIGHT. ESTIMATED DELIVERY DATE IS (B)(6) 2020. FDA SAFETY REPORT ID # (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
766780 MINIMED 670G INSULIN PUMP AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-1780

Patients

Seq Age Sex Outcome Treatment
1 58 YR Required Intervention