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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number MMT-722NAS
Medical Device Problem Code Application Program Version or Upgrade Problem (2881)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/11/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
 
Event or Problem Description
Information received by medtronic indicated that the insulin pump had a insulin pump error alarm.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.
 
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Brand Name
PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS
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 Key10166733
Report Number2032227-2020-132987
Device Sequence Number13989083
Product Code OYC
UDI-Device Identifier00643169478558
UDI-Public(01)00643169478558
Combination Product (Y/N)N
Initial Reporter CountryMX
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/18/2020
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
Operator of Device Lay User/Patient
Device Model NumberMMT-722NAS
Device Catalogue NumberMMT-722NAS
Device Lot NumberB3722NASJ
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/12/2020
Initial Report FDA Received Date06/18/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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