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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-751NAP
Device Problem Inaccurate Delivery (2339)
Patient Problem Overdose (1988)
Event Date 03/07/2016
Event Type  Malfunction  
Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event. The device has been returned, but not yet evaluated. Further information will follow once the analysis has been completed. No conclusion can be drawn at this time.

 
Event Description

It was reported that the customer is calling regarding the scroll wrap. Customer stated that the insulin pump showed she needed 1. 1 units of insulin and she only wanted to take half a unit, so she pushed down one time and gave herself 20 units of insulin. The customer's blood glucose was unknown.

 
Manufacturer Narrative

The insulin pump passed self test, a21 error test, rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test; the operating currents within specifications. However, the insulin pump was received with cracked case at the display window corners, cracked belt clip slot and minor scratches on the lcd window.

 
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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 Key5529548
MDR Text Key41541781
Report Number3004209178-2016-94822
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,Followup
Report Date 03/07/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/28/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-751NAP
Device Catalogue NumberMMT-751NAP
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/23/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2016
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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