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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAP ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAP ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751NAP
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); High Test Results (2457)
Patient Problem Hyperglycemia (1905)
Event Date 02/01/2018
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 reported via phone call that they experienced high blood glucose. The customer¿s blood glucose level was 514 mg/dl. The customer was treated with insulin pens. Customer also reported that lcd screen was damaged. Customer was always high because she cannot read the screen so she cannot bolus. The customer declined troubleshoot for high blood glucose. The insulin pump will be returned for analysis.
 
Manufacturer Narrative
Device received with intermittent button response due to flattened dome switch on up arrow and down arrow button. Connector was inspected and locked on lcd board. No button error alarm during testing. Device passed displacement test, self test, rewind test, basic occlusion test, prime test, excessive no delivery test and occlusion test. Device received with corroded battery tube and minor scratches on display window noted.
 
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Brand Name530G INSULIN PUMP MMT-751NAP
Type of DeviceARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
Manufacturer Contact
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
MDR Report Key7640459
MDR Text Key112418545
Report Number3004209178-2018-85365
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeUS
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 08/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-751NAP
Device Catalogue NumberMMT-751NAP
Device Lot NumberA4751NAPJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2015
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: 06/27/2018 Patient Sequence Number: 1
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