• 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-1715K 630G BLACK MG 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-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715K
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hyperglycemia (1905)
Event Date 04/18/2022
Event Type  Injury  
Event Description
The customer family member reported via phone call that they were hospitalized due to high blood glucose with 1043 mg/dl. The customer¿s current blood glucose value was 98 mg/dl. The customer did not experienced symptoms due to high blood glucose. The customer treated high blood glucose with insulin drip. The insulin pump was not on auto mode at the time of incident. Customer had been using insulin pump system within 48 hours of reported high blood glucose event. Troubleshooting was performed. No further patient complications were reported.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name630G INSULIN PUMP MMT-1715K 630G BLACK MG
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 Key14459937
MDR Text Key292214120
Report Number2032227-2022-192775
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 05/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/20/2021
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG2GUYH
Was Device Available for Evaluation? No
Date Manufacturer Received05/16/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/21/2018
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: 05/20/2022 Patient Sequence Number: 1
Treatment
FRN-MMT-332-RSVR, UNOMED INF SET
-
-