• 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 Problems Nonstandard Device (1420); Improper or Incorrect Procedure or Method (2017)
Patient Problem Hypoglycemia (1912)
Event Date 10/08/2017
Event Type  Injury  
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.
 
Event Description
The customer's parent reported via phone call that the customer had experienced multiple issues of severe low blood glucose values, including an incident in (b)(6) 2017 that required emt assistance. Prior to the june hypoglycemic incident, the customer was playing basketball and wearing the insulin pump. The customer experienced convulsions due to the low blood glucose. The patient was treated by ems and was not taken to the hospital. Additionally, the customer experienced a low blood glucose on (b)(6) 2017. He was given 64 ounces of (b)(6) and his blood glucose increased to 30 mg/dl. He also treated with glucose tablets. The caller believed that the insulin pump was over-delivering. During troubleshooting it was confirmed that the device programming was accurate. The insulin pump had not been wore during an mri or in proximity to powerful magnetic fields. The caller also mentioned that they had been re-using reservoirs, and the caller was advised against re-using consumables. The customer also had multiple boxes of infusion sets, one of which were specified for product recall. The insulin pump will be returned for analysis.
 
Manufacturer Narrative
Pump passed the functional test, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test and displacement test. Unit functioning properly. No delivery anomaly noted during testing. Unit received with minor scratched lcd window and cracked retainer. A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing. After testing it was concluded that the device operated within specifications.
 
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 Key6953365
MDR Text Key89455415
Report Number2032227-2017-58993
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 12/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/16/2017
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 NumberHG1GJJH
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/14/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-