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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 Obstruction of Flow (2423)
Patient Problems Diarrhea (1811); Headache (1880); Hyperglycemia (1905); Vomiting (2144)
Event Date 04/17/2022
Event Type  Injury  
Event Description
It was reported via phone call that customer experienced high blood glucose level.Customer's blood glucose value was 24 mmol/l at the time of the incident.The customer declined troubleshooting for high blood glucose.The customer stated that the symptoms related to high blood glucose such as vomiting, diarrhea and headache.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.The customer was neither in the emergency room, nor admitted into hospital as a result of high blood glucose.Customer did not allege insulin pump was under delivering.Customer reported that the pump had insulin flow blocked alarm.No further complications were reported.The customer will continue to use the product.
 
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.
 
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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 Key14167912
MDR Text Key289755746
Report Number2032227-2022-182085
Device Sequence Number1
Product Code OZO
UDI-Device Identifier000000763000315702
UDI-Public(01)000000763000315702
Combination Product (y/n)N
Reporter Country CodeAS
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 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2022
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 NumberHG4MHK0
Was Device Available for Evaluation? No
Date Manufacturer Received04/19/2022
Date Device Manufactured09/02/2020
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 INF SET
Patient Outcome(s) Other;
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