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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Renal Failure (2041)
Event Date 08/28/2021
Event Type  Death  
Manufacturer Narrative
(b)(4). Retainer ring
=
clear, the unit did not have a battery installed when received. Unit 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. History download was successful using thus and (b)(6) upload was successful. Unit had minor scratched display window, scratched display window cover, scratched case, cracked battery tube threads, cracked case at the battery tube side, pillowing keypad overlay, cracked keypad overlay at the select button and cracked retainer. The test p-cap and reservoir does lock in place in the reservoir compartment.
 
Event Description
Customer¿s daughter reported via phone call that the customer passed away in hospital. The customer was hospitalized on (b)(6) 2021 due to covid. The caller stated that the cause of death was covid, kidney failure. The customer¿s blood glucose was unknown at the time of death. The customer was not wearing the insulin pump at the time of death. The insulin pump had been disconnected 48 hours prior to passing. The caller agreed to return the insulin pump for analysis.
 
Manufacturer Narrative
Retainer ring
=
clear. Patient passing reported on (b)(6) 2021. Date of customer passing (b)(6) 2021. Device was returned with no allegations. The device did not have a battery installed when received. Device 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 delivery accuracy test at 0. 0871 inches. History download was successful using thus and carelink upload was successful. Device had minor scratched display window, scratched display window cover, scratched case, cracked battery tube threads, cracked case at the battery tube side, pillowing keypad overlay, cracked keypad overlay at the select button and cracked retainer. The test p-cap and reservoir does lock in place in the reservoir compartment. Data analysis: (b)(6) 2021 daily total of all insulin delivered
=
51. 575; (b)(6) 2021 daily total of all insulin delivered
=
22. 375; (b)(6) 2021 daily total of all insulin delivered
=
30; (b)(6) 2021 daily total of all insulin delivered
=
30; (b)(6) 2021 daily total of all insulin delivered
=
30; (b)(6) 2021 daily total of all insulin delivered
=
30; (b)(6) 2021 daily total of all insulin delivered
=
30. Device tested ok with no device problems found. Device was returned with no allegations.
 
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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 Key12577915
MDR Text Key274789129
Report Number2032227-2021-201474
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 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2021
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 NumberHG3BNCN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received10/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2019
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: 10/05/2021 Patient Sequence Number: 1
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