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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 Backflow (1064)
Patient Problems Bruise/Contusion (1754); Dyspnea (1816); Hemorrhage/Bleeding (1888); Hyperglycemia (1905)
Event Date 03/02/2017
Event Type  Injury  
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
Customer reported via phone call that they were experiencing high blood glucose readings of 500 mg/dl and have been treating with manual injections. Customer stated that blood was going into the tubing instead of insulin. Customer mentioned bleeding at site and bruising. Customer's blood glucose reading at the time of the call was 358 mg/dl and has treated with the insulin pump. Customer further reported difficulty breathing due to the high blood glucose readings. Troubleshooting was conducted and the drive support cap and all settings appeared to be normal. Customer called back to perform the high pressure test and it passed. Product is being returned for analysis.
 
Manufacturer Narrative
The insulin pump passed the functional testing, including the operating currents measurement, self-test, unexpected restart error test, displacement test, rewind, basic occlusion, occlusion, prime and excessive no delivery test. The insulin pump had cracked case at display window corner, belt clip slot, minor scratched and cracked display 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 Key6468644
MDR Text Key72058565
Report Number3004209178-2017-99818
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,Followup
Report Date 04/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2017
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? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2017
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

Patient Treatment Data
Date Received: 04/06/2017 Patient Sequence Number: 1
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