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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL

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MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL Back to Search Results
Model Number MMT-1780KPK
Device Problems Circuit Failure (1089); Battery Problem (2885); Power Problem (3010)
Patient Problem Hyperglycemia (1905)
Event Date 09/29/2019
Event Type  Malfunction  
Manufacturer Narrative

Unit power up properly after battery installation. Unit received with operating currents within spec. Unit passed selftest, rewind, seating, basic occlusion test, occlusion test, force sensor test and displacement test. The adapt tool confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) was within spec range. No power error 25 or power loss alarm noted during testing or in the pump trace download. Pump error 63 (variable 12) was confirmed in the pump history, problem isolated to electronic assemblies. (b)(4).

 
Event Description

Information received by medtronic indicated that their insulin pump had power detected alarm and hardware low level failure alarm. Customer was unable to clear alarm. Customer reported that they performed self test and test was passed. No harm requiring medical intervention was reported. The insulin pump will be returned for analysis.

 
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Brand NamePUMP MMT-1780KPK 670G PATHWAY BLACK MG
Type of DeviceARTIFICIAL 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
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
00777-3869
Manufacturer Contact
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
  00777-3869
8185464805
MDR Report Key10216226
MDR Text Key197202659
Report Number2032227-2020-139205
Device Sequence Number1
Product Code OZP
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 06/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-1780KPK
Device Catalogue NumberMMT-1780KPK
Device LOT NumberHG2WZFF
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/09/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/23/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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