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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-751NAS
Device Problem Air Leak (1008)
Patient Problems Dehydration (1807); Fatigue (1849); Hyperglycemia (1905); Blurred Vision (2137); Urinary Frequency (2275); Palpitations (2467)
Event Date 03/20/2017
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 they were hospitalized on (b)(6) 2017 due to dehydration and high blood glucose. The customer was at the airport when she began feeling tired and her heart beat was going really fast so they had called the hospital. The customer's blood glucose level at the time of admission was 526 mg/dl. The customer was wearing the insulin pump at the time of the hospitalization. The customer had symptoms of being dehydrated, blurry vision, and going to the restroom a lot. Her high blood glucose was treated with a syringe and a bottle of insulin. It was noted during troubleshooting that there were two air bubbles along the tubing length. The customer was able to clear out the air bubbles. There were no leaks. The customer had already changed the set 4 times at the hospital. The customer will continue to monitor the insulin pump. The device will not return 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 Key6509859
MDR Text Key73331699
Report Number3004209178-2017-46411
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
PMA/PMN Number
120010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 03/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-751NAS
Device Catalogue NumberMMT-751NAS
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 Received03/23/2017
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: 04/20/2017 Patient Sequence Number: 1
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