• 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-1715KL 630G 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-1715KL 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715KL
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2022
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. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.
 
Event Description
Information received by medtronic indicated that insulin pump was over delivering. No harm requiring medical intervention was reported. Troubleshooting was successfully performed however the customer will discontinue the use of device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name630G INSULIN PUMP MMT-1715KL 630G
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
00777-3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
00777-3869
Manufacturer Contact
tricha miles
ceiba norte ind. park #50 road
juncos 00777--386
  00777-3869
7635140379
MDR Report Key13652665
MDR Text Key296692001
Report Number2032227-2022-119913
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
Type of Report Initial
Report Date 03/02/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-1715KL
Device Catalogue NumberMMT-1715KL
Device Lot NumberHG4B0DH
Was Device Available for Evaluation? No
Date Manufacturer Received02/25/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/12/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-