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

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.

• Brand Name: PUMP MMT-1714K 630G BLACK MMOL CANADA
• 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; * 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 Key: 9876477
• MDR Text Key: 184811889
• Report Number: 3004209178-2020-90116
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169782396
• UDI-Public: (01)00643169782396
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1714K
• Device Catalogue Number: MMT-1714K
• Device Lot Number: HG2KHRW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 03/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1