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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-751NAL
Device Problem No Display/Image (1183)
Patient Problems Fall (1848); Hypoglycemia (1912)
Event Date 04/08/2017
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
The customer's father reported via phone call that the insulin pump had blank display. The customer's father reported that they fall over due to low blood glucose of 29 mg/dl. The customer's father reported that the screen popped out of the insulin pump. The customer's blood glucose was 40 mg/dl at the time of incident. The customer's father stated that they treated the low blood glucose with food. The customer's father was advised that the insulin pump will need to be replaced. The customer was advised to disconnect from the insulin pump and revert to back-up plan. The insulin pump was returned for analysis.
 
Manufacturer Narrative
The insulin pump was received with cracked and bleeding lcd glass. Unable to perform operating currents, self-test, unexpected restart error test, rewind test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test due to cracked and bleeding lcd glass. The insulin pump had minor scratched lcd window, cracked lcd window, cracked case at the display window corners, cracked battery tube threads, broken reservoir tube lip and stained end cap sticker.
 
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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 Key6551799
MDR Text Key74641030
Report Number3004209178-2017-76914
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 other
Type of Report Initial,Followup
Report Date 05/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-751NAL
Device Catalogue NumberMMT-751NAL
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2017
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: 05/08/2017 Patient Sequence Number: 1
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