• 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. PUMP MMT-1715KM 630G 3ML BLACK MEDI   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. PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715KM
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Bruise/Contusion (1754)
Event Date 04/12/2020
Event Type  malfunction  
Manufacturer Narrative
Unit received with missing retainer ring and reservoir tube lip o-ring. Unable to perform displacement test and p-cap or reservoir will not lock properly due to missing retainer. Unit received with minor scratched lcd window, cracked case (battery tube), cracked case-corner of belt clip rails, and cracked battery tube threads. (b)(4).
 
Event Description
Information received by medtronic indicated that the crack and scratches on the back of the insulin pump and screen. No harm requiring medical intervention was reported. The insulin pump will be returned for analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePUMP MMT-1715KM 630G 3ML BLACK MEDI  
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
8185464805
MDR Report Key10161218
MDR Text Key196081873
Report Number2032227-2020-131913
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 05/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-1715KM
Device Catalogue NumberMMT-1715KM
Device Lot NumberHG1XZZB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2020
Is the Reporter a Health Professional? No
Date Manufacturer Received10/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/10/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberZ-0955-2020

-
-