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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-751NAP
Device Problem Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Death (1802); Renal Failure (2041)
Event Date 12/26/2014
Event Type  Death  
Event Description

It was reported that the customer passed away at home, in hospice care. The cause of death was complications from c. Diff (clostridium difficile). The customer was hospitalized on (b)(6) 2014 for a minor foot surgery. The customer went to rehabilitation and acquired c. Diff. The customer's kidneys stopped functioning. He had a heart attack in 2009. The customer's blood glucose at the time of death was unknown. The customer was not wearing the insulin pump at the time of death; it was removed at the hospital when he was hospitalized for surgery on (b)(6) 2014. It caller did not know if the customer used sensors. The caller stated that she does not have the insulin pump and cannot send it for analysis because the device was taken from the customer at the hospital; she was told that c. Diff stays attached to the device for two years. The caller did not have the device at the time call so the serial number could not be verified. No further information is available at this time.

 
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.

 
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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 386
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50
road 31 km 24.4
juncos PR 00777 386
Manufacturer Contact
christopher tupper
18000 devonshire street
northridge, CA 91325-1219
8185764313
MDR Report Key4410686
MDR Text Key5279523
Report Number3004209178-2015-82913
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 01/09/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-751NAP
Device Catalogue NumberMMT-751NAP
Was Device Available For Evaluation? No
Date Manufacturer Received01/09/2015
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: 01/12/2015 Patient Sequence Number: 1
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