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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-723NAS; 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-723NAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number MMT-723NAS
Device Problems Device Displays Incorrect Message (2591); Electromagnetic Compatibility Problem (2927)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/04/2017
Event Type  malfunction  
Manufacturer Narrative
This mdr related to the (b)(4)manufacturing site has been assigned a medwatch number from the medtronic minimed (b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
 
Event Description
The customer reported via phone call that the insulin pump had a motor error alarm, a motor position encoder error alarm, and an additional error alarm.The customer stated that the device had been exposed to high magnetic fields.Blood glucose level at the time of the incident was 126 mg/dl.The customer was advised that the insulin pump would be replaced and agreed to return the product for analysis.
 
Manufacturer Narrative
The information provided for the product code and common device name with the initial report was incorrect.The correct information has been provided with this report.
 
Manufacturer Narrative
Findings: motor error alarm during rewind due to motor encoder signal out of phase.Pump passed the stop current and run current tests.Unable to verify motor position encoder error alarm, motion sensor test failure alarm or perform the self test, off no power test, unexpected restart error test, displacement test, prime test, occlusion test and no delivery test due to motor error alarm.Pump had cracked case at display window corner, battery tube threads, reservoir tube lip, belt clip slot and minor scratched display window.
 
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Brand Name
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS
Type of Device
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
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
Manufacturer Contact
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
MDR Report Key6675205
MDR Text Key78774025
Report Number2032227-2017-24478
Device Sequence Number1
Product Code OYC
UDI-Device Identifier00643169507258
UDI-Public(01)00643169507258
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial,Followup,Followup
Report Date 08/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMMT-723NAS
Device Catalogue NumberMMT-723NAS
Device Lot NumberB5723NASJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/04/2017
Initial Date FDA Received06/28/2017
Supplement Dates Manufacturer Received08/09/2017
08/09/2017
Supplement Dates FDA Received08/18/2017
08/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age42 YR
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