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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 Bacterial Infection (1735); Death (1802); Hyperglycemia (1905); Renal Failure (2041)
Event Date 12/17/2015
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 in a hospital. The customer was hospitalized on (b)(6) 2015. The cause of death was (b)(6). The customer had kidney failure; stage 3 or 4 renal disease. The customer's blood glucose at the time of death was 250 mg/dl. The customer was not wearing the insulin pump at the time of death. It was disconnected on (b)(6) 2015 by the instructions of the hospital. They stated that the hospital staff would treat the customer's blood glucose. The customer was not using sensors. The caller stated that they do not know where the insulin pump is and declined returning it 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 Key5369038
MDR Text Key36022703
Report Number3004209178-2016-81373
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
PMA/PMN Number120010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Type of Report Initial
Report Date 01/13/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/14/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
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 Received01/13/2016
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: 01/14/2016 Patient Sequence Number: 1
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