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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 Problem Hyperglycemia (1905)
Event Date 08/13/2021
Event Type  malfunction  
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Brand NamePUMP MMT-1714K 630G BLACK MMOL CANADA
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 Key14460881
Report Number2032227-2022-193162
Device Sequence Number1
Product Code OZO
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
Type of Report Initial
Report Date 05/20/2022
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? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-1714K
Device Catalogue NumberMMT-1714K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2022
Date Manufacturer Received05/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/11/2018
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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