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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-751NAH ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAH ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751NAH
Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Moisture or Humidity Problem (2986)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/28/2018
Event Type  malfunction  
Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. The device will be returned for analysis and 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 that the insulin pump had some motor error. The customer's blood glucose level was 180 mg/dl. The customer was assisted with the troubleshooting. The customer stated that the insulin pump was exposed to the moisture. The insulin pump will be returned for the analysis.
 
Manufacturer Narrative
Insulin pump received with blank display and constant tone due to moisture damage on the electronics assembly. Unable to perform all functional testing including the operating currents, unexpected restart error test, rewind, basic occlusion, occlusion, prime, unexpected restart error and excessive no delivery test due to blank display. Insulin pump received with moisture damage motor, vibrator, keypad and battery tube assembly.
 
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Brand Name530G INSULIN PUMP MMT-751NAH
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 Key7358122
MDR Text Key103314019
Report Number3004209178-2018-58458
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 09/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-751NAH
Device Catalogue NumberMMT-751NAH
Device Lot NumberA3751NAHJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2018
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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