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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-523NAB; 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-523NAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number MMT-523NAB
Medical Device Problem Code Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/20/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No button error alarm noted during testing.Unit had unresponsive all buttons due to corroded keypad traces.No unexpected numbers ramping/scrolling during testing.
 
Event or Problem Description
It was reported that the insulin pump had a keypad anomaly.Blood glucose value was 97 mg/dl at the time of the incident.The caller stated that they were unable to get insulin delivery due to keypad anomaly.Troubleshooting was not able to be performed.The keypad anomaly was not fixed.The insulin pump will be returned for analysis.
 
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Brand Name
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAB
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 Key8328628
Report Number3004209178-2019-53904
Device Sequence Number139849
Product Code OYC
UDI-Device Identifier00643169446380
UDI-Public(01)00643169446380
Combination Product (Y/N)N
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) 02/11/2019
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-523NAB
Device Catalogue NumberMMT-523NAB
Device Lot NumberB2523NABJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/07/2019
Initial Report FDA Received Date02/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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