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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number MMT-1712K
Device Problem Moisture or Humidity Problem
Event Date 07/23/2019
Event Type  Malfunction  
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. The insulin pump involved in this event is the 640g insulin infusion pump, which is not marketed in the united states. However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.

 
Event Description

It was reported that the insulin pump had critical pump error. Customer's blood glucose level was unknown. Customer also stated that the insulin pump was exposed to moisture. The device will be returned for analysis.

 
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Brand Name640G INSULIN PUMP MMT-1712K
Type of DevicePUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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
8185464805
MDR Report Key8849214
Report Number2032227-2019-39136
Device Sequence Number1
Product CodeOYC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/31/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/31/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-1712K
Device Catalogue NumberMMT-1712K
Device LOT NumberHG23Q9X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/30/2017
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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