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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 Problems Break (1069); Excess Flow or Over-Infusion (1311); Connection Problem (2900); Environmental Compatibility Problem (2929)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)
Event Date 04/16/2022
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. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time.
 
Event Description
The customer reported via phone call that they experienced low blood glucose, which resulted in a hospitalization. Customer's blood glucose value was 40 mg/dl at the time of the incident. Customer's current blood glucose level was 89 mg/dl. The customer was assisted with troubleshooting for low blood glucose. The customer reported symptoms such as not able to speak and move, having jerky movements, unconscious. Customer had been using insulin pump system within 48 hours of reported low blood glucose event. It was unknown that auto mode feature was active or not at the time of event. Customer experience high blood glucose level of 543 mg/dl. Customer declined troubleshoot for high blood glucose level as the customer was off the insulin pump. Customer reported that the insulin pump was exposed to high magnetic field. Customer did allege insulin pump was over delivering. Customer performed displacement test. The insulin pump did pass the test. Customer reported insulin pump had loose retainer ring and broken battery compartment. Customer stated that the reservoir was not able to lock in place. The customer will discontinue use of the device.
 
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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
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
Manufacturer Contact
tricha miles
ceiba norte ind. park #50 road
juncos 00777--386
7635140379
MDR Report Key14295224
MDR Text Key290955886
Report Number2032227-2022-183202
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,Followup
Report Date 06/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2022
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 NumberHG1SR7A
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received06/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/13/2017
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: 05/06/2022 Patient Sequence Number: 1
Treatment
FRN-MMT-332-RSVR, UNOMED INF SET
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