• 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 Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/03/2018
Event Type  malfunction  
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. 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
Customer reported via phone call that insulin pump alarmed for critical pump error and they had red x as well as open book on screen as customer jumped into the swimming pool. Customer's insulin pump was beeping and flashing due to critical pump error. Customer had high blood glucose of 333mg/dl and declined troubleshoot for high blood glucose. Customer advised to discontinue use of the pump and recommended customer refer to back up plan. Insulin pump will be return for analysis.
 
Manufacturer Narrative
Device received with critical pump error and unable to download due to corroded electronic assemblies. Device received with corroded battery tube and corroded motor home switch. Device received with minor scratches on case, cracked select button keypad overlay, pillowing keypad overlay, cracked case corner of the belt clip rails near the battery compartment, cracked retainer, faded serial number label and minor scratches on lcd window.
 
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 Key7330160
MDR Text Key102081446
Report Number3004209178-2018-56061
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 other
Type of Report Initial,Followup
Report Date 06/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG1CU6C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/06/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-