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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 Excess Flow or Over-Infusion (1311); Patient Device Interaction Problem (4001)
Patient Problems Fatigue (1849); Hypoglycemia (1912); Weakness (2145); Sweating (2444); Shaking/Tremors (2515)
Event Date 08/12/2020
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. Blood glucose reading was 43 mg/dl and 193 mg/dl. Customer stated insulin pump alleging possible over delivery because retainer ring damaged. Customer experienced symptom such as shaking, sweating, weakness, fatigue. Customer treated with food and chocolate. Customer was using insulin pump system within 48 hours of reported low blood glucose event. Customer was neither in emergency room nor admitted into hospital. Customer stated reservoir retainer ring had crack and able to lock in place. The insulin pump will be and reservoir will not be returned for analysis.

 
Manufacturer Narrative

Device passed the self test, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and delivery accuracy test at 0. 08690 inches. No discolored retainer noted. Device received with cracked retainer. (b)(4).

 
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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
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
8185464805
MDR Report Key10447797
MDR Text Key204182079
Report Number2032227-2020-167995
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 10/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/25/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/14/2018
Device MODEL NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device LOT NumberHG2G1RW
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/01/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/12/2018
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: 08/25/2020 Patient Sequence Number: 1
Treatment
UNOMED INF SET
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