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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KR 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KR 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715KR
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problem Hyperglycemia (1905)
Event Date 04/26/2022
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 they experienced high blood glucose and visited emergency room. The customer¿s blood glucose level was 469 mg/dl at the time of incident. The customer¿s current blood glucose value was 243 mg/dl. The customer did not experienced symptoms due to high blood glucose. The customer treated high blood glucose with insulin drip and injection. 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. The customer did not allege under delivery on insulin pump. No further patient complications were reported. Troubleshooting was successfully performed however the customer will continue use of the device. Frn-(b)(4), unomed inf set.
 
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Brand Name630G INSULIN PUMP MMT-1715KR 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 Key14454232
MDR Text Key292519376
Report Number2032227-2022-192664
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 05/19/2022
1 Device was Involved in the Event
0 Patients were 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 Model NumberMMT-1715KR
Device Catalogue NumberMMT-1715KR
Device Lot NumberHG4QYJ6
Was Device Available for Evaluation? No
Date Manufacturer Received05/17/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/05/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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