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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-551NAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-551NAB
Device Problems Fluid Leak (1250); Device Displays Incorrect Message (2591); Material Protrusion/Extrusion (2979)
Patient Problem Hyperglycemia (1905)
Event Date 06/01/2018
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 level and their insulin pump received compromised force sensor system alarm as well as drive support cap was protruded. The customer¿s blood glucose level was 464 mg/dl. Customer declined to troubleshooting for high blood glucose level. The customer also reported that the insulin was squirting during manual prime process. The customer was also advised revert to back up plan and treat per healthcare professional¿s instructions. The insulin pump will be returned for analysis.
 
Manufacturer Narrative
Unable to confirm compromised force sensor system alarm and unable to perform displacement test, basic occlusion test, occlusion test due to reservoir tube lip broken off. The test reservoir does not stay locked in place due to reservoir tube lip broken off. Unable to perform prime test and excessive no delivery test due to loose or protruded drive support disk. No moisture damage on electronics and motor assembly noted.
 
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Brand Name530G INSULIN PUMP MMT-551NAB
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 Key7653433
MDR Text Key112838393
Report Number3004209178-2018-86736
Device Sequence Number0
Product Code OZO
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 Received06/29/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberMMT-551NAB
Device Catalogue NumberMMT-551NAB
Device Lot NumberA3551NABJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2018
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 Manufactured06/26/2014
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: 06/29/2018 Patient Sequence Number: 1
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