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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-723NAP; 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-723NAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number MMT-723NAP
Date of Event 06/10/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Insulin pump alarmed motor error during rewind due to motor encoder signal out of phase.Unable to perform operating currents, self test, unexpected error test, rewind test, basic occlusion test, occlusion test, prime, compromised force sensor system test, excessive no delivery test and displacement test or verify failed battery alarm due to motor error alarms.
 
Event or Problem Description
The customer reported via phone call that insulin pump had motor error and had bubbles in the line and was able to resolve it herself and did not call.The customer had more than one motor error alarm within the last 30 days.The blood glucose at the time of the incident was unknown.The customer was assisted with troubleshooting.The device will be returned for analysis.
 
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Brand Name
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAP
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
MDR Report Key8821313
Report Number2032227-2019-35400
Device Sequence Number2541140
Product Code OYC
UDI-Device Identifier00643169077720
UDI-Public(01)00643169077720
Combination Product (Y/N)N
Initial Reporter StateDC
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) 07/24/2019
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-723NAP
Device Catalogue NumberMMT-723NAP
Device Lot NumberA7723NAPJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/15/2019
Initial Report FDA Received Date07/24/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
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