SENSOR MMT-7020C1 GS3 5PK 9L OUS1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for SENSOR MMT-7020C1 GS3 5PK 9L OUS1 manufactured by Medtronic Minimed.

Event Text Entries

[185913534] Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.
Patient Sequence No: 1, Text Type: N, H10


[185913535] It was reported that the sensor had inaccurate readings that triggered threshold suspend alarm. The customers blood glucose levels were 20. 9 mmol/l and sensor glucose levels were 13. 6 mmol/l at the time of the incident. The customer reported having issues with the sensor. The customer was informed that their blood glucose and sensor glucose levels were not in acceptable range. The sensor will not return for analysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2032227-2020-102092
MDR Report Key9908703
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-20
Date Mfgr Received2020-03-20
Device Manufacturer Date2019-09-05
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactGERWIN DE GRAAFF
Manufacturer Street18000 DEVONSHIRE ST.
Manufacturer CityNORTHRIDGE CA 913251219
Manufacturer CountryUS
Manufacturer Postal913251219
Manufacturer Phone8185464805
Manufacturer G1MEDTRONIC MINIMED
Manufacturer Street18000 DEVONSHIRE ST.
Manufacturer CityNORTHRIDGE CA 913251219
Manufacturer CountryUS
Manufacturer Postal Code913251219
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSENSOR MMT-7020C1 GS3 5PK 9L OUS1
Generic NameARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
Product CodeOZP
Date Received2020-03-31
Model NumberMMT-7020C1
Catalog NumberMMT-7020C1
Lot NumberI059
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC MINIMED
Manufacturer Address18000 DEVONSHIRE ST. NORTHRIDGE CA 913251219 US 913251219


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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