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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 Problems Material Discolored (1170); Device Operates Differently Than Expected (2913)
Patient Problem Fall (1848)
Event Date 03/14/2017
Event Type  malfunction  
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. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time.
 
Event Description
The customer reported via phone call that the insulin pump had a display anomaly after he fell while wearing the device. Blood glucose level near the time of the incident was 77 mg/dl. The caller stated that there was a black line on the screen, and when the act button was pressed, a portion of the display went black. Customer stated that he was unable to read the display. The customer was advised that the insulin pump would be replaced and agreed to return the device for analysis.
 
Manufacturer Narrative
The insulin pump was received with cracked and bleeding lcd glass also, unable to perform self-test, unexpected restart error test, displacement test, rewind, basic occlusion test, occlusion test, operating currents, prime test, off no power test and excessive no delivery test due to cracked and bleeding glass. The insulin pump had cracked reservoir tube lip, minor scratched display window and cracked case at the display window corner.
 
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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 Key6491948
MDR Text Key72949769
Report Number3004209178-2017-42963
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,Followup
Report Date 04/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-751NAS
Device Catalogue NumberMMT-751NAS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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