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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 Problems Device Inoperable (1663); Transmitter (3141)
Patient Problems Bacterial Infection (1735); Diarrhea (1811); Hyperglycemia (1905); Vomiting (2144); Diabetic Ketoacidosis (2364)
Event Date 02/11/2015
Event Type  Injury  
Event Description

It was reported that the customer was hospitalized on (b)(6) 2015 with a blood glucose level of 558 mg/dl. Customer did not have a working transmitter and had less than usual control. Customer ended up with diabetic ketoacidosis and a c. Difficile infection. Customer just got out of the hospital. Customer was vomiting and had diarrhea for two weeks. Customer was not wearing the pump at the time of the hospitalization. Customer was off the pump from the time to get to the hospital, which was approximately 5 minutes. No further assistance needed.

 
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 Key4547488
MDR Text Key5517111
Report Number3004209178-2015-97162
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 Consumer
Reporter Occupation
Type of Report Initial
Report Date 02/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2015
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
Is The Reporter A Health Professional? No
Date Manufacturer Received02/14/2015
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: 02/25/2015 Patient Sequence Number: 1
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