• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Problem False Reading From Device Non-Compliance (1228)
Patient Problem Hypoglycemia (1912)
Event Date 07/06/2017
Event Type  Injury  
Manufacturer Narrative
Additional information has been received which was not included with the initial medwatch report. The additional information has been provided with this report.
 
Event Description
The customer reported via phone call that they had inaccurate sensor readings. The customer's sensor glucose values were 26, 59, 177, 58, 64 and 122 mg/dl while the blood glucose values were 59, 82, 236, 37, 26, 61 and 177 mg/dl. The customer treated with food. Customer stated the insulin pump shows he is in suspend on low but sensor was not connected. Customer performed troubleshooting for sensor issues but declined troubleshooting for low blood glucose. The insulin pump will not be returned for analysis. The sensor will be returned for analysis.
 
Manufacturer Narrative
Additional information has been received which was not included with the initial medwatch report. The additional information has been provided with this report. Follow up one was not submitted. The information has been provided with this report.
 
Event Description
The customer reported via phone call that they had inaccurate sensor readings. The customer's sensor glucose values were 26, 59, 177, 58, 64 and 122 mg/dl while the blood glucose values were 59, 82, 236, 37, 26, 61 and 177 mg/dl. The customer treated with food. Customer stated the insulin pump shows he is in suspend on low but sensor was not connected. Customer performed troubleshooting for sensor issues but declined troubleshooting for low blood glucose. The insulin pump will not be returned for analysis. The sensor will be returned for analysis.
 
Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.
 
Event Description
The customer reported via phone call that they had inaccurate sensor readings. The customer's blood glucose during the incident was 26 mg/dl while the sensor was reading at 64 mg/dl. The customer treated with food. Customer stated the insulin pump shows he is in suspend on low but sensor is not connected. Customer performed troubleshooting for sensor issues but declined troubleshooting for low blood glucose. The insulin pump will not be returned for analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7265086
MDR Text Key103716113
Report Number3004209178-2018-50213
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
Report Date 03/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG1QS0F
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/17/2017
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: 02/12/2018 Patient Sequence Number: 1
-
-