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 Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Reaction, Injection Site (2442)

Event Date 02/04/2019

Event Type  malfunction  

Manufacturer Narrative

Unit power up properly after battery installation.Unit received with operating currents within spec.Unit passed rewind, seating, basic occlusion test, occlusion test, force sensor test and displacement test.No unexpected insulin flow blocked alarms noted.Unit received with the audio alert functioning properly.No audio alert anomaly noted.Unit alarmed hardware low level failures during self test and confirmed in the pump history due to broken pin 6 trace (sda) on u1 keypad assembly.Unit received with faded serial number label.

Event Description

The customer reported via phone call that the back of insulin pump was damaged.The customer¿s blood glucose level was 249 mg/dl at the time of incident.Customer stated that the insulin pump had no delivery alarm.Customer was assisted with troubleshoot and insulin was exited by changing complete set.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 ; 8185464805
• MDR Report Key: 8881986
• MDR Text Key: 154285345
• Report Number: 2032227-2019-44705
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00763000090197
• UDI-Public: (01)00763000090197(17)210410
• 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: 08/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/10/2021
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG2FYVW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Date Manufacturer Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2018
• 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
• Patient Age: 47 YR
• Patient Weight: 235