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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-522NAS; 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-522NAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number MMT-522NAS
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/26/2018
Event Type  malfunction  
Manufacturer Narrative
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 the insulin pump had prime rewind and insulin squirted out if the tubing during manual prime.The customer¿s blood glucose was unknown.Customer states they did not receive 2nd series of beeps nor did numbers appear on the screen.The insulin pump will be returned for analysis.
 
Manufacturer Narrative
Motor error alarm during the basic occlusion test due to loose or protruded drive support disk.Unable to confirm prime or fill anomaly due to motor error alarm noted.
 
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Brand Name
PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAS
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 Key7629284
MDR Text Key112201541
Report Number3004209178-2018-84372
Device Sequence Number1
Product Code OYC
UDI-Device Identifier00613994271440
UDI-Public(01)00613994271440
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
Report Date 09/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMMT-522NAS
Device Catalogue NumberMMT-522NAS
Device Lot NumberA2522NASJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received08/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/20/2007
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 Age61 YR
Patient Weight6
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