MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715K

Device Problems Break (1069); Component Falling (1105)

Patient Problem Hyperglycemia (1905)

Event Date 08/16/2017

Event Type  malfunction  

Manufacturer Narrative

The test reservoir does not lock in place and unable to perform the displacement test due to missing retainer and missing reservoir tube o-ring.The insulin pump was received with scratched case, pillowing keypad overlay, broken reservoir tube lip and minor scratched lcd window.

Event Description

The customer reported via phone call that their insulin pump was damaged.The customer¿s blood glucose level was 279mg/dl.Troubleshooting was performed for damage and noticed the o-ring had fallen out and is missing.Advised the device will need to be replaced.Advised to discontinue use of the insulin pump and revert to a back-up plan.The insulin pump will be returned for analysis.

• Brand Name: 630G INSULIN PUMP MMT-1715K 630G BLACK MG
• 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: 7602709
• MDR Text Key: 111456244
• Report Number: 3004209178-2018-81653
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169656840
• UDI-Public: (01)00643169656840
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2018

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-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG1F876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2016
• 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
• Patient Age: 49 YR
• Patient Weight: 302