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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAP; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAP; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751NAP
Device Problems Sticking (1597); Failure to Deliver (2338); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/31/2018
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 several issues.Customer¿s blood glucose was unknown at the time of incident.Customer stated that the insulin pump had a no delivery.Buttons were hard to press, had a possible rewind anomaly, and cracks in the insulin pump casing.No troubleshooting was performed.Insulin pump is not expected to return for analysis.
 
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Brand Name
530G INSULIN PUMP MMT-751NAP
Type of Device
ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
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 Key7644562
MDR Text Key112707335
Report Number3004209178-2018-85879
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00643169404335
UDI-Public(01)00643169404335
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
Report Date 06/27/2018
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-751NAP
Device Catalogue NumberMMT-751NAP
Device Lot NumberA2751NAPJ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/31/2018
Initial Date FDA Received06/28/2018
Date Device Manufactured04/11/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age25 YR
Patient Weight140
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