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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-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751NAS
Device Problems Mechanical Problem (1384); Device Difficult to Program or Calibrate (1496); Patient Device Interaction Problem (4001)
Patient Problem Bacterial Infection (1735)
Event Date 02/07/2019
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

The customer reported via phone call that the insulin pump had a motor error, insulin squirted out during priming and buttons were harder to press. The customer¿s blood glucose level was unknown at the time of the incident. Customer was hospitalized due to an amputation due to infection, not due to high or low blood glucose. The insulin pump will not be returned for analysis.

 
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Brand Name530G INSULIN PUMP MMT-751NAS
Type of DeviceARTIFICIAL 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
8185464805
MDR Report Key8338624
MDR Text Key136113896
Report Number3004209178-2019-55654
Device Sequence Number1
Product Code OZO
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
Type of Report Initial
Report Date 02/14/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/14/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-751NAS
Device Catalogue NumberMMT-751NAS
Device LOT NumberA2751NASJ
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/03/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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