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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1714K
Device Problems No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Patient Problem Pregnancy (3193)
Event Date 11/23/2019
Event Type  malfunction  
Manufacturer Narrative
Unit received with missing retainer ring and reservoir tube lip o-ring. Unit received with partially broken off piece at the reservoir tube lip. Unable to perform displacement test and p-cap / reservoir will not lock properly due to missing retainer. (b)(4).
 
Event Description
Information received by medtronic indicated that there was a crack under the clear ring on the reservoir compartment. The customer also reported that the reservoir lip ring was damaged. The customer also reported that the insulin pump had cosmetic damage. The customer reported that the reservoir was able to lock in place when inserted into insulin pump. No harm requiring medical intervention was reported. The device will be returned for analysis.
 
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Brand NamePUMP MMT-1714K 630G BLACK MMOL CANADA
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
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 Key9876477
MDR Text Key184811889
Report Number3004209178-2020-90116
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-1714K
Device Catalogue NumberMMT-1714K
Device Lot NumberHG2KHRW
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/26/2018
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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