PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS

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 INSULIN INFUSION PUMP MMT-722NAS manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[186356212] Insulin pump received with scratches on lcd display window noted. The test reservoir was able to lock in place. Pump received with no button response due to moisture damage to keypad traces noted. Unable to verify failed battery test and unexpected restart error system. (b)(4). 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


[186356213] Information received by medtronic indicated that insulin pump had scratched on the screen. No harm requiring medical intervention was reported. The customer was assisted with troubleshooting. Customer stated that insulin pump was rejected new battery and changed every three days. The device will not be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-92460
MDR Report Key9908865
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2019-05-24
Date Mfgr Received2020-03-23
Device Manufacturer Date2007-02-23
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 StreetCEIBA NORTE IND. PARK #50 ROAD
Manufacturer CityJUNCOS 00777-386
Manufacturer Country*
Manufacturer Postal00777-3869
Manufacturer Phone8185464805
Manufacturer G1MEDTRONIC PUERTO RICO OPERATIONS CO.
Manufacturer StreetCEIBA NORTE IND. PARK #50 ROAD
Manufacturer CityJUNCOS 00777-386
Manufacturer Country*
Manufacturer Postal Code00777-3869
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS
Generic NamePUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
Product CodeOYC
Date Received2020-03-31
Returned To Mfg2019-10-21
Model NumberMMT-722NAS
Catalog NumberMMT-722NAS
Lot NumberA2722NASJ
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC PUERTO RICO OPERATIONS CO.
Manufacturer AddressCEIBA NORTE IND. PARK #50 ROAD JUNCOS 00777-386 * 00777-3869


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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