SENSOR ENLITE MMT-7008A

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 ENLITE MMT-7008A manufactured by Medtronic Minimed.

Event Text Entries

[185914201] 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


[185914202] Information indicated by medtronic that the customer inserted the needle but the needle did not come out. Customer stated that it was bent in the body. Customer tried 3 different sensors in the belly and the last one the needle did not come out at all and customer tried to pull the needle out it hurts. No harm requiring medical intervention was reported. The device will not be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2032227-2020-102091
MDR Report Key9908657
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-20
Date Mfgr Received2020-03-20
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 ENLITE MMT-7008A
Generic NameARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Product CodeOZO
Date Received2020-03-31
Model NumberMMT-7008A
Catalog NumberMMT-7008A
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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