• 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. 530G INSULIN PUMP MMT-751NAS 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. 530G INSULIN PUMP MMT-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751NAS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hyperglycemia (1905); Skin Erosion (2075); Skin Irritation (2076)
Event Date 10/24/2018
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. 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 the customer experienced hyperglycemia. The customer blood glucose level was over 441 mg/dl at the time of incident and the current blood glucose level is 331 mg/dl. The customer experienced symptoms such as nauseated and weak. Customer is ok with the troubleshoot. The customer was treated with manual injections for high blood glucose level. The insulin pump will not be returned for analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name530G INSULIN PUMP MMT-751NAS
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 Key8040880
MDR Text Key126213747
Report Number2032227-2018-56251
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 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-751NAS
Device Catalogue NumberMMT-751NAS
Device Lot NumberA6751NASJ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/28/2017
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: 11/06/2018 Patient Sequence Number: 1
Treatment
UNOMEDICAL INFUSION SETFRN RESERVOIR
-
-