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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-751NAB
Device Problem Failure to Deliver (2338)
Patient Problems Bacterial Infection (1735); Hyperglycemia (1905); Diabetic Ketoacidosis (2364)
Event Date 01/08/2016
Event Type  Injury  
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

The customer reported via phone call of issues with their insulin pump. The customer states the pump is not delivering the insulin like it needs to be. The customer states they have ended up at the hospital. The customer states they are no longer hospitalized and not currently on the pump. The customer states they had issues with no delivery alarm. The customer's blood glucose level at the time of hospitalization was over 600mg/dl. The customer states they were hospitalized for high blood glucose, diabetic ketoacidosis and strep throat. The customer states the no delivery alarm was resolved with a complete set change. The customer was advised to call back as soon as issues arise in order to troubleshoot.

 
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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 Key5402644
MDR Text Key37300190
Report Number3004209178-2016-84417
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 PATIENT
Type of Report Initial
Report Date 01/15/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/01/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-751NAB
Device Catalogue NumberMMT-751NAB
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2016
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: 02/01/2016 Patient Sequence Number: 1
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