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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1714K
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hyperglycemia (1905); Polydipsia (2604); Dysuria (2684)
Event Date 11/18/2021
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 were experienced high blood glucose level.Customer¿s blood glucose level was 26.9 mmol/l at the time of incident.Customer was treated with insulin pump high blood glucose level.Customer reported symptoms like thirst, frequent urination and feeling ill.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.The auto mode feature was not active at time of high blood glucose event.Customer reported that current blood glucose value was 7.4 mmol/l.Customer accepted troubleshooting for high blood glucose level.The insulin pump will not be returned for analysis.
 
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Brand Name
PUMP MMT-1714K 630G BLACK MMOL CANADA
Type of Device
ARTIFICIAL 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 Key13051260
MDR Text Key282699615
Report Number2032227-2021-233105
Device Sequence Number1
Product Code OZO
UDI-Device Identifier000000643169782396
UDI-Public(01)000000643169782396
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMMT-1714K
Device Catalogue NumberMMT-1714K
Device Lot NumberHG2ZYX9
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/15/2021
Initial Date FDA Received12/21/2021
Date Device Manufactured11/29/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
FRN-UNK-RSVR, UNOMED SET
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