• 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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Myocardial Infarction (1969)
Event Date 08/16/2021
Event Type  Death  
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
It was reported via phone call that the customer passed away in hospital on (b)(6) 2021. The customer was hospitalized on (b)(6) 2021 due to had a hard fall and had history of by bypass surgery. The caller stated that the customer had a hard fall and had history of bypass surgery that eventually lead to heart attack that may have lead to customer's passing. The customer's blood glucose was unknown at the time of death. Customer was not wearing the insulin pump at the time of passing. Customer had last worn the insulin pump on (b)(6) 2021. The customer was not using sensor at the time of passing. It was unknown that the caller will returned the insulin pump for analysis.
 
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 Key12486499
MDR Text Key271847821
Report Number2032227-2021-194292
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 09/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-1715KL
Device Catalogue NumberMMT-1715KL
Device Lot NumberHG4PQCA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/23/2020
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: 09/17/2021 Patient Sequence Number: 1
Treatment
FRN-MMT-332-RSVR, UNOMED SET
-
-