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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-712 PARADIGM INSULIN PUMP; PUMP, INFUSION, INSULIN

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MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-712 PARADIGM INSULIN PUMP; PUMP, INFUSION, INSULIN Back to Search Results
Model Number MMT-712EWS
Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/25/2018
Event Type  malfunction  
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
 
Event Description
Customer reported via phone call that the insulin pump had a keypad anomaly and the buttons were unresponsive.Customer¿s blood glucose was unknown at the time of incident.No troubleshooting was performed.Insulin pump is not expected to return for analysis.
 
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Brand Name
MMT-712 PARADIGM INSULIN PUMP
Type of Device
PUMP, INFUSION, INSULIN
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 Key7604418
MDR Text Key111670193
Report Number3004209178-2018-81876
Device Sequence Number1
Product Code LZG
UDI-Device Identifier00613994469694
UDI-Public(01)00613994469694
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 06/15/2018
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-712EWS
Device Catalogue NumberMMT-712EWS
Device Lot NumberA9712EWSJ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/25/2018
Initial Date FDA Received06/15/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/11/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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