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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 Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Pneumonia (2011)
Event Date 07/22/2019
Event Type  malfunction  
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 were hospitalized due to high blood glucose, pneumonia and high blood pressure on (b)(6) 2019 with blood glucose of 900 mg/dl. The customer was treated with manual injection and insulin drip. Customer has been using insulin pump system within 48 hours of reported high blood glucose event. Customer report customer did not allege insulin pump was under delivering. Customer reports insulin exited at the quick release. The customer was wearing the insulin pump during the hospitalization. The insulin pump will be returned for analysis.
 
Manufacturer Narrative
Device passed the functional tests, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and dat at 0. 08670 inches. Device received with scratched case, pillowing keypad overlay and minor scratched lcd window. (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 Key8954456
MDR Text Key156262246
Report Number2032227-2019-56091
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00763000090197
UDI-Public(01)00763000090197(17)210404
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 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/04/2021
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG2FHA9
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/05/2018
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: 09/03/2019 Patient Sequence Number: 1
Treatment
FRN-UNK-RSVR, UNOMED SET
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