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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-751LNAP
Device Problems Device Displays Incorrect Message (2591); Electromagnetic Compatibility Problem (2927)
Patient Problems Fall (1848); Hyperglycemia (1905); Hypoglycemia (1912); Pain (1994); Diabetic Ketoacidosis (2364)
Event Date 02/08/2017
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
Customer reported via phone call that they were hospitalized due to high blood glucose readings of 500 mg/dl to 600 mg/dl and diabetes ketoacidosis. Customer stated that they fell and hurt their ribs. Customer also mentioned experiencing low blood glucose readings of 30 mg/dl in the past. Customer stated that they treated with food and glucose tablets. It was noted that the customer was experiencing the threshold suspend alarm and stated that the insulin pump was shutting off. Troubleshooting was performed and the drive support cap and all settings appeared to be normal. It was noted that the insulin pump was exposed to a high magnetic field. No delivery alarm was also noted in the alarm history. Customer was advised to monitor the insulin pump and to talk to their health care provider. No product is being returned 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 Key6362933
MDR Text Key68469746
Report Number3004209178-2017-93192
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
Type of Report Initial
Report Date 02/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-751LNAP
Device Catalogue NumberMMT-751LNAP
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 Received02/22/2017
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: 02/27/2017 Patient Sequence Number: 1
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