• 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 OZO

  • 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 OZO Back to Search Results
Model Number MMT-751NAL
Device Problem Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Death (1802); Fever (1858); Pneumonia (2011); Cancer (3262)
Event Date 11/07/2015
Event Type  Death  
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

It was reported that customer passed away in the hospital on (b)(6) 2015. Customer had a high fever due to a bacterial infection. Customer was admitted into the hospital on (b)(6) 2015. Customer's blood glucose at the time of admittance was unknown. Customer's blood glucose at time of death was unknown. Customer's cause of death was pneumonia, bacterial infection and pancreatic cancer. Customer also had kidney failure. Customer was not wearing insulin pump due to customer canceling appointment for insulin pump training; customer never began insulin pump therapy. Customer was not wearing insulin pump at the time of death. Customer was not wearing sensor at the time of death.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name530G INSULIN PUMP
Type of DeviceOZO
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50
road 31 km 24.4
juncos PR 00777 3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50
road 31 km 24.4
juncos PR 00777 3869
Manufacturer Contact
gerwin de graaff
18000 devonshire street
northridge, CA 91325-1219
8185764805
MDR Report Key5437331
MDR Text Key38204551
Report Number3004209178-2016-87135
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
PMA/PMN Number120010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Type of Report Initial
Report Date 02/12/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/15/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-751NAL
Device Catalogue NumberMMT-751NAL
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 02/15/2016 Patient Sequence Number: 1
-
-