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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 Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/25/2020
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
Information received by medtronic indicated that the insulin pump had a critical pump error.Customer stated that insulin pump performed safety and open book image was found.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.
 
Manufacturer Narrative
Device received with critical pump error due to corroded electronic assemblies.Unable to perform self test, rewind, seating, basic occlusion test, occlusion test, force sensor test or displacement test due to critical pump error.Device received with corroded battery tube, corroded motor home switch, scratched case, pillowing keypad overlay, cracked battery tube threads, cracked case corner of the belt clip rails near the battery compartment, missing display window cover and cracked keypad overlay.The p-cap does lock properly.
 
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Brand Name
PUMP MMT-1715KM 630G 3ML BLACK MEDI
Type of Device
ARTIFICIAL 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 Key11099867
MDR Text Key225748688
Report Number2032227-2020-222687
Device Sequence Number1
Product Code OZO
UDI-Device Identifier000000643169873834
UDI-Public(01)000000643169873834
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 02/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMMT-1715KM
Device Catalogue NumberMMT-1715KM
Device Lot NumberHG1LXR5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2021
Initial Date Manufacturer Received 12/25/2020
Initial Date FDA Received12/31/2020
Supplement Dates Manufacturer Received02/02/2021
Supplement Dates FDA Received02/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/20/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age73 YR
Patient Weight124
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