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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715K
Device Problems Battery (420); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/02/2017
Event Type  Malfunction  
Manufacturer Narrative

Insulin pump passed sleep current measurement, active current measurement, self test and displacement test. No unexpected low battery alarm noted during testing. Pump trace download analysis confirmed the pump alarmed power loss alarm, replace battery alert, replace battery now alarm. The power management tool indicated abnormal behavior of the lithium backup battery loaded voltage (loaded vlith) as shown on the power management graph and confirmed power loss alarm, replace battery alert and replace battery now alarm due to connector resistance j6 /pcb 1. After disconnecting and reconnecting the internal battery connector on j6/pcb 1, the pump was monitored and functioned properly. Unit was received with partially detached reservoir retainer, scratched case, minor scratched lcd window and faded serial number label.

 
Event Description

The customer reported via phone call that insulin pump had battery issue. The blood glucose at the time of the incident was unknown. The device will be returned for analysis.

 
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Brand Name630G INSULIN PUMP MMT-1715K 630G BLACK MG
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 Key7649743
MDR Text Key112871811
Report Number3004209178-2018-86563
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 07/09/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/29/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device LOT NumberHG1CPZY
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/20/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/29/2016
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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