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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-523LNAS; 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-523LNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number MMT-523LNAS
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem Hyperglycemia (1905)
Event Date 06/05/2018
Event Type  Injury  
Manufacturer Narrative
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 Description
The customer reported via phone call the insulin pump had a keypad anomaly.The customer¿s blood glucose was 478mg/dl at the time of incident.Customer stated that the insulin pump buttons are not responding and pump suspended.No significant events leading to keypad anomaly were observed.Keypad anomaly troubleshooting was performed and confirmed that time is advancing.The customer was advised to discontinue use of pump and revert to back-up plan.The insulin pump is being replaced and is expected to return for analysis.
 
Manufacturer Narrative
No button error alarm noted during testing.Unit had unresponsive esc and act buttons due to corroded keypad traces.Unable to perform self-test, rewind test, basic occlusion test, occlusion test, prime/compromised force sensor system test, excessive no delivery test and displacement test or verify no delivery alarm, empty reservoir and low reservoir alarm due to unresponsive button.
 
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Brand Name
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAS
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
8185464805
MDR Report Key7657879
MDR Text Key112996415
Report Number3004209178-2018-87273
Device Sequence Number1
Product Code OYC
UDI-Device Identifier00643169151314
UDI-Public(01)00643169151314
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 Other
Type of Report Initial,Followup
Report Date 07/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMMT-523LNAS
Device Catalogue NumberMMT-523LNAS
Device Lot NumberA2523LNASJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received07/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2014
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 Outcome(s) Other;
Patient Age68 YR
Patient Weight160
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