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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. KIT MMT-1760KPK 670G PATHWAY BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
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MEDTRONIC PUERTO RICO OPERATIONS CO. KIT MMT-1760KPK 670G PATHWAY BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL Back to Search Results
Model Number MMT-1760KPK
Medical Device Problem Codes Computer Software Problem (1112); Communication or Transmission Problem (2896)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/25/2020
Type of Reportable Event Malfunction
Additional 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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
 
Event or Problem Description
Information received by medtronic indicated that the insulin pump had multiple insulin pump error alarms.Customer stated they were unable to clear the alarm.Troubleshooting was performed.No harm requiring medical intervention was reported.The insulin pump will not be returned for analysis.
 
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Brand Name
KIT MMT-1760KPK 670G PATHWAY BLACK MG
Common Device Name
ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
*  00777-3869
MDR Report Key10107592
Report Number2032227-2020-125104
Device Sequence Number3122571
Product Code OZP
UDI-Device Identifier00763000283445
UDI-Public(01)00763000283445
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/01/2020
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
Operator of Device Lay User/Patient
Device Model NumberMMT-1760KPK
Device Catalogue NumberMMT-1760KPK
Device Lot NumberHG3XEDB
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/25/2020
Initial Report FDA Received Date06/02/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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