Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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; INSULIN INFUSION PUMP / SENSOR AUGMENTED
  • 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; INSULIN INFUSION PUMP / SENSOR AUGMENTED Back to Search Results
Model Number MMT-1715K
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Congestive Heart Failure (1783); Death (1802); Hyperglycemia (1905); Unspecified Infection (1930); Myocardial Infarction (1969); Neuropathy (1983)
Event Date 04/12/2017
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
 
Event Description
It was reported that the customer passed away at home, in his sleep.The cause of death was heart attack.The caller stated that diabetes and congestive heart failure were the illnesses that lead to the customer's death.The customer had neuropathy, issues with the eye sight, soars on the body, dark spots on the toes and fingers, had strokes, and, few weeks prior to passing, had blood infection.The caller stated that the customer was supposed to go to the emergency room for the infection, but did not want to.The caller did not know the customer's blood glucose at the time of death, however stated that the monday prior to passing it was 146 mg/dl, but then it dropped.The customer was not wearing the insulin pump at the time of death; the customer chose not to wear it.The caller did not know how long prior to passing the device was disconnected.The customer was not using sensors.The caller does not know the whereabouts of the customer's insulin pump.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
630G INSULIN PUMP
Type of Device
INSULIN INFUSION PUMP / SENSOR AUGMENTED
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 Key6519577
MDR Text Key73621495
Report Number3004209178-2017-47101
Device Sequence Number1
Product Code OYC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 04/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/20/2017
Initial Date FDA Received04/25/2017
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 Unknown
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age51 YR
Patient Weight92
-
-