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 Problem Inaccurate Delivery (2339)

Patient Problem Hyperglycemia (1905)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr related to the (b)(4) manufacturing site has been assigned a medwatch number from the medtronic minimed (b)(4) site, per variance 5.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 Description

The customer reported via phone call the insulin pump had a delivery anomaly and a button error.The customer¿s blood glucose was 14.5 mmol/l at the time of incident.Customer stated that the insulin pump alarmed button error while troubleshooting for delivery anomaly.Customer confirmed that the insulin exited after a 5.0 unit fill cannula was delivered.No button error troubleshooting was performed.The insulin pump is not expected to return 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
• 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
• MDR Report Key: 7072798
• MDR Text Key: 93652291
• Report Number: 2032227-2017-69378
• 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: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• 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: HG22UVZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2017
• 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