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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)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/22/2017
Event Type  malfunction  
Manufacturer Narrative
The information provided with the initial report was not complete. The information has been provided with this report. The device alarmed motor error during rewind due to motor encoder signal out of phase. We were unable to confirm encoder signal out alarm or perform the displacement test, prime test, occlusion test and no delivery test due to motor error alarm. The insulin pump had a cracked case at display window corner, reservoir tube lip, belt clip slot and minor scratched display window.
 
Manufacturer Narrative
The information provided with the initial report was not complete. The information has been provided with this report. The device alarmed motor error during rewind due to motor encoder signal out of phase. We were unable to confirm encoder signal out alarm or perform the displacement test, prime test, occlusion test and no delivery test due to motor error alarm. The insulin pump had a cracked case at display window corner, reservoir tube lip, belt clip slot and minor scratched display window. Follow up report two was not submitted. The correct information has been provided with this report.
 
Manufacturer Narrative
(b)(4). 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 call the insulin pump alarmed motor encoder position error. The customer was assisted with troubleshooting. The customer¿s blood glucose level was unknown at the time of the incident. The customer stated that the drive support cap appeared normal. The customer stated that the insulin pump was exposed to magnetic resonance imaging. The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan. The insulin pump will be returned for analysis.
 
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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 Key6828874
MDR Text Key100046072
Report Number2032227-2017-42122
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,Followup,Followup
Report Date 03/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2017
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 NumberA4751NAHJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2018
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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