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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 Hypoglycemia (1912); Injury (2348)
Event Date 07/06/2016
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 that she was recently hospitalized with two broken legs and with insulin issues. The customer broke her first leg on (b)(6) 2016 due to a low blood glucose level. Her father called the ambulance. Her blood glucose level was 24 mg/dl when the ambulance arrived and was taken to the hospital. She may have tripped on a rug and broke her second leg in the beginning of (b)(6). She was admitted into the hospital again but this time it was non-diabetes related. The customer was given packets to treat her low blood glucose level. She was wearing the insulin pump at the time of hospitalization. The second time she was hospitalized she was off the insulin pump for less than 48 hours. The device was not returned.

 
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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 MINIMED
18000 devonshire street
northridge CA 91325 1219
Manufacturer Contact
gerwin de graaff
18000 devonshire street
northridge, CA 91325-1219
8185764805
MDR Report Key6086774
MDR Text Key59418949
Report Number2032227-2016-40663
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 11/02/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2016
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
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/02/2016
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: 11/08/2016 Patient Sequence Number: 1
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