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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-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715K
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Hypoglycemia (1912)
Event Date 02/12/2022
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 low blood glucose. Customer's blood glucose was 43 mg/dl and the current blood glucose was 49 mg/dl. Customer declined troubleshooting for low blood glucose. The insulin pump will not be returned for the analysis.
 
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Brand Name630G INSULIN PUMP MMT-1715K 630G BLACK MG
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 Key13540057
MDR Text Key285669448
Report Number2032227-2022-114218
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
Type of Report Initial
Report Date 02/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG47X15
Was Device Available for Evaluation? No
Date Manufacturer Received02/12/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/31/2020
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: 02/16/2022 Patient Sequence Number: 1
Treatment
FRN-MMT-UNK-RSVR, UNOMED SET
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