PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754DES

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 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754DES manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[186356945] Unit received with blank display due to corroded battery tube. Unable to perform operating currents, self-test, a21 error test and displacement test or verify low batt alarm due to blank display. Unit had stripped battery cap coin slot (p), cracked battery tube threads. Reservoir tube lip was inspected and no anomaly was noted. The insulin pump involved in this event is the paradigm real-time veo insulin infusion pump, which is not marketed in the united states. However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.
Patient Sequence No: 1, Text Type: N, H10


[186356946] Information received by medtronic indicated that the insulin pump had a pump error alarm. The customer stated they were not able to clear the alarm and were not able to complete the rewind process. (details that led to the event and add relevant information if applicable). No harm requiring medical intervention was reported. The insulin pump was returned for analysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-92405
MDR Report Key9908459
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2019-11-11
Date Mfgr Received2020-03-24
Device Manufacturer Date2014-12-03
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-754DES
Generic NamePUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
Product CodeOYC
Date Received2020-03-31
Returned To Mfg2020-02-18
Model NumberMMT-754DES
Catalog NumberMMT-754DES
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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