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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number MMT-723NAB
Date of Event 04/18/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Insulin pump received with cracked battery tube threads and stripped battery cap coin slot noted.The test reservoir p-cap was able to lock in place.Pump received with blank display due to corroded battery cap contact noted.Unable to verify charge, battery anomaly due to blank display.However, using a test battery cap, the unit powered up properly and no blank display or charge/ battery anomaly noted during testing.Pump passed displacement test, self test, off no power test and all operating currents tested within the spec.
 
Event or Problem Description
Information received by medtronic indicated that the insulin pump had issues with battery draining faster.The customer stated that the insulin pump had blank display.The customer stated that the insulin pump had cracked at battery compartment.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.
 
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Brand Name
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB
Common Device Name
PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
*  00777-3869
MDR Report Key10188186
Report Number2032227-2020-136036
Device Sequence Number16968454
Product Code OYC
UDI-Device Identifier00643169077690
UDI-Public(01)00643169077690
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/24/2020
1 Device was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Model NumberMMT-723NAB
Device Catalogue NumberMMT-723NAB
Device Lot NumberA6723NABJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/18/2020
Initial Report FDA Received Date06/24/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
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