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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 Problems Break (1069); Nonstandard Device (1420)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 07/28/2020
Event Type  Injury  
Event Description
Medtronic received information that battery cap cracked/damaged occurred. There was an allegation of hypertension as a result of this event.
 
Manufacturer Narrative
2032227-060322-002-c. (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 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 Key14849132
MDR Text Key294908819
Report Number2032227-2022-249318
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
Remedial Action Recall
Type of Report Initial
Report Date 06/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/27/2022
Device Model NumberMMT-1715KL
Device Catalogue NumberMMT-1715KL
Device Lot NumberHG3JZZ2
Was Device Available for Evaluation? No
Date Manufacturer Received07/28/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/28/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction Number2032227-060322-002-C

Patient Treatment Data
Date Received: 06/28/2022 Patient Sequence Number: 1
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