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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-551NAP
Device Problems Device Inoperable (1663); Use of Device Problem (1670)
Patient Problems Fall (1848); Hyperglycemia (1905); Hypoglycemia (1912)
Event Date 04/04/2017
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 called to report that the insulin pump was not working. Customer reported a hospitalization due to falling and breaking her leg, and did not know if the fall was due to low blood glucose readings or not. Customer's blood glucose reading before the fall was 34 mg/dl and then drank juice. Customer's blood glucose reading at the time of call was 185 mg/dl; reading at time of hospital admission was 64 mg/dl. Customer was wearing device during admission. The customer performed troubleshooting and found that the device wanted to fill but there was no reservoir in the device. Customer was assisted and was able to rewind and use the insulin pump. Customer stated that she thought her low blood glucose reading the day of the fall was due to being nervous. The device was not replaced or 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 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 Key6496239
MDR Text Key72886362
Report Number3004209178-2017-43997
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 04/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-551NAP
Device Catalogue NumberMMT-551NAP
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 Received04/11/2017
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: 04/15/2017 Patient Sequence Number: 1
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