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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-1715KL 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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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 Fatigue (1849); Hyperglycemia (1905)
Event Date 06/14/2021
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 level. The customer¿s blood glucose level was 573 mg/dl at the time of the incident. Customer stated that they felt tired due to high blood glucose. Customer was treated with insulin pump. Customer had been using insulin pump system within 48 hours of reported high blood glucose event. Auto mode feature was not used at the time of event. The device will not be returned for analysis.
 
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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 Key12038325
MDR Text Key257404595
Report Number2032227-2021-159410
Device Sequence Number1
Product Code OZO
UDI-Device Identifier000000763000367053
UDI-Public(01)000000763000367053(17)240511
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2021
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 NumberHG5AWSN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/12/2021
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: 06/22/2021 Patient Sequence Number: 1
Treatment
FRN-MMT-332-RSVR, UNOMED INF SET
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