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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP OZO

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP OZO Back to Search Results
Model Number MMT-751NAL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stacking Breaths (1593); Death (1802); High Blood Pressure/ Hypertension (1908)
Event Date 12/10/2016
Event Type  Death  
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
It was reported that the customer passed away at home. The cause of death was coronary artery disease, hypertension and diabetes type 1. The caller stated that the customer had called the paramedics. The caller found the customer slumped over in the bathroom; she was not breathing. The caller stated that they went to bed, and, sometime during the night, the customer was fighting indigestion and had shortness of breath. The caller tried cpr until the paramedics' arrival; however, the customer could not be revived. The caller did not know the customer's blood glucose at the time of death. The customer was wearing the insulin pump at the time of death. The customer was not using sensors. The caller stated that they no longer have the customer's insulin pump. The insulin pump information used on this medwatch report is the last known insulin pump to have been issued to the customer.
 
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Brand Name530G INSULIN PUMP
Type of DeviceOZO
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50
road 31 km 24.4
juncos PR 00777 3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50
road 31 km 24.4
juncos PR 00777 3869
Manufacturer Contact
gerwin de graaff
18000 devonshire street
northridge, CA 91325-1219
8185764805
MDR Report Key6340964
MDR Text Key67727306
Report Number3004209178-2017-91301
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
PMA/PMN Number
120010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 02/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-751NAL
Device Catalogue NumberMMT-751NAL
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/17/2017 Patient Sequence Number: 1
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