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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-751NAS
Device Problem Obstruction of Flow (2423)
Patient Problems Arteriosclerosis (1722); Death (1802); Fainting (1847); Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Vomiting (2144)
Event Date 03/05/2017
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 hypertension and ulterior sclerosis, and secondary cause of diabetes. The caller sated that the customer had been vomiting all night on (b)(6) 2017. The caller did not know the customer's blood glucose at the time of death, however, the last known blood glucose was around 500 mg/dl on sunday morning of (b)(6) 2017. In the morning of (b)(6) 2017, at 10:45am, the customer had fainted when getting out of his truck. The customer was not wearing the insulin pump at the time of death; it was found on the side of the bed. The customer had mentioned that he thinks the device might be clogged. The caller did not know how long the customer had been off the insulin pump. The caller did not know if the customer used sensors or not. The caller declined returning the insulin pump for analysis.
 
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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 Key6426368
MDR Text Key70623235
Report Number3004209178-2017-96152
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 03/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-751NAS
Device Catalogue NumberMMT-751NAS
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2017
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: 03/22/2017 Patient Sequence Number: 1
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