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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 Patient Device Interaction Problem (4001)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 01/10/2020
Event Type  Injury  
Manufacturer Narrative
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. (b)(4).
 
Event Description
The customer reported via phone call that they were hospitalized for low blood glucose and seizure. The customer's blood glucose level at the time of incident was in between 30mg/dl to 40 mg/dl. Customer was treated with food and sugar water. Customer also stated that the clip was broken. The insulin pump will not be returned for analysis.
 
Manufacturer Narrative
The initial report had the incorrect information. (b)(4).
 
Event Description
Customer stated that they only dispatched emergency medical service. Customer was not hospitalized.
 
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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
MDR Report Key9846617
MDR Text Key183888631
Report Number3004209178-2020-87252
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/12/2021
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG2NPLL
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/18/2020 Patient Sequence Number: 1
Treatment
FRN-MMT 332A UNOMED SET; FRN-MMT 332A UNOMED SET
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