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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-1715KR 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KR 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715KR
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problem Renal Failure (2041)
Event Date 01/18/2020
Event Type  Death  
Event Description
It was reported via phone call that the customer passed away in hospital on (b)(6) 2020. The customer was hospitalized on (b)(6) 2019 due to kidney failure. The cause of death was kidney failure. The caller stated that the customer had kidney issue that may have led to the customer's passing. The customer¿s blood glucose was unknown mg/dl at the time of death. The customer was not wearing the insulin pump at the time of death. The insulin pump had been disconnected on december 28, 2019. The caller was returned the insulin pump for analysis. Frn-mmt-332a , unomed inf set. The case is reported only for the f. A results.
 
Manufacturer Narrative
(b)(4). S/w 4. 10c. Retainer ring
=
clear. Date of customer passing: (b)(6) 2020. The insulin pump had minor scratched display window, scratched case, pillowing keypad overlay and cracked retainer. The test p-cap and reservoir does lock in place in the reservoir compartment. History download was successful using thus and carelink upload was successful. The pump passed the functional test, 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 the dat test at 0. 0871 inches. The insulin pump did not have a battery installed when received. Please see below for the date range listed in the formatted history file. The formatted history file lists data from (b)(6) 2019 to (b)(6) 2019. The pump passed the functional testing. A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing. After testing it was concluded that the device operated within specifications.
 
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Brand Name630G INSULIN PUMP MMT-1715KR 630G
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 Key13017082
MDR Text Key282320593
Report Number2032227-2021-231265
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 Other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 04/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-1715KR
Device Catalogue NumberMMT-1715KR
Device Lot NumberHG3553L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received10/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberZ-0955-2020

Patient Treatment Data
Date Received: 12/16/2021 Patient Sequence Number: 1
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