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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-751LNAL ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751LNAL ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751LNAL
Device Problems No Display/Image (1183); Moisture Damage (1405); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/25/2017
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
The customer called in and states that she went in the ocean and forgot to take the pump off and there is water in the screen of the pump. The display went blank immediately after pump exposure to moisture. The customer's blood sugar is unknown. The insulin pump will return.
 
Manufacturer Narrative
The insulin pump was received with blank display and constant tone due to moisture damage on the electronics assembly. We were unable to perform all functional testing including the operating currents test, unexpected restart error test, rewind test, basic occlusion test, occlusion test, prime test and excessive no delivery test due to blank display. The insulin pump was received with moisture damage motor, vibrator, keypad and battery tube assembly. The insulin pump was received with cracked case at the display window corner, cracked reservoir tube lip, minor scratched lcd window, cracked belt clip slot, cracked case reservoir tube window corner and cracked battery tube threads.
 
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Brand Name530G INSULIN PUMP MMT-751LNAL
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 Key6727149
MDR Text Key80632296
Report Number2032227-2017-30032
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00643169507760
UDI-Public(01)00643169507760
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 09/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-751LNAL
Device Catalogue NumberMMT-751LNAL
Device Lot NumberA4751LNALJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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