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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 No Display/Image (1183); Battery Problem (2885); Device Operates Differently Than Expected (2913)
Patient Problem Hyperglycemia (1905)
Event Date 05/25/2018
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 got blank display as well as some battery issue. The customer¿s experienced different blood glucose level was 331, 303, 300 mg/dl. Troubleshooting was performed. Customer stated that they receive battery out limit or the failed battery or weak battery. Customer was already getting a replacement battery cap and that did not resolve issue. The insulin pump will be returned for analysis.

 
Manufacturer Narrative

Device passed displacement test, rewind test, basic occlusion test, prime test, excessive no delivery test, occlusion test, self test and unexpected restart error test. Device passed all operating currents tested within the specification range and passed off no power test. Device was monitored and tested with no blank display, weak battery alarm, failed battery test, bad battery alarm and unexpected battery out limit alarm noted. Device received with corroded battery tube 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 Key7631920
MDR Text Key112224989
Report Number3004209178-2018-84432
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 08/12/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/22/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-551NAB
Device Catalogue NumberMMT-551NAB
Device LOT NumberA3551NABJ
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/20/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/09/2014
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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