PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-XXX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-XXX manufactured by Medtronic Minimed.

Event Text Entries

[185914561] 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


[185914562] Customer reported via phone call possible over delivery alarm. Customer's blood glucose level was 60 mg/dl. Customer believed the insulin pump over delivered insulin while they experienced low blood glucose levels. Customer declined to troubleshoot. The insulin pump will not be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2032227-2020-102090
MDR Report Key9908396
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-22
Date Mfgr Received2020-03-22
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 NamePARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
Generic NamePUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
Product CodeOYC
Date Received2020-03-31
Model NumberMMT-XXX
Catalog NumberMMT-XXX
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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