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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715KM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/18/2021
Event Type  Death  
Event Description
Information received by medtronic indicated that the customer passed away at home. The customer was hospitalized on (b)(6) 2021 due to alzheimer. The cause of death was alzheimer. 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 will be returned for analysis. The case is reported only for the f. A results.
 
Manufacturer Narrative
(b)(4). Updated analysis summary by (b)(6) on (b)(6) 2022. S/w 2. 8c, retainer ring
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clear. On (b)(6) 2021 the pump was returned due to patient passing away, but not alleging device. 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 dat test at 0. 0874 inches. Device uploaded properly using carelink and thus. Device had minor scratched display window, scratched display window cover, scratched case, cracked battery tube threads, cracked case at the corner of the belt clip rail, pillowing keypad overlay and cracked retainer. The test p-cap and reservoir does lock in place in the reservoir compartment. Data analysis: the formatted history file lists data from 11/20/2018 to 12/22/2020 and on 01/16/2021. (b)(6) 2020 20:01:21. 000 user time date change, event type
=
3, source id
=
pump (ngp is in open loop state); history record length
=
19, old system time
=
(b)(6) 2020 20:01:21. 000, new system time
=
(b)(6)2021 19:07:22. 000. In summary, pump passed all required testing. Pump was not returned for an allegation.
 
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Brand NamePUMP MMT-1715KM 630G 3ML BLACK MEDI  
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 Key13390795
MDR Text Key286880617
Report Number2032227-2022-107004
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
Report Date 05/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-1715KM
Device Catalogue NumberMMT-1715KM
Device Lot NumberHG2Q2KB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received10/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2018
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

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