MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751LNAP; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-751LNAP

Device Problems Fluid/Blood Leak (1250); Failure to Deliver (2338); Device Fell (4014)

Patient Problem Hyperglycemia (1905)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

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

Customer reported via phone call that insulin pump had several issues.Customer reported that rewind was louder than normal, pump had a few no delivery alarms, insulin squirt during rewind, alarm would clear prior to changing infusion set and insulin pump fell off while wearing it.Customer also reported of being hospitalized in the intensive care unit due to high blood glucose.Insulin pump is not expected to return for failure analysis.

• Brand Name: 530G INSULIN PUMP MMT-751LNAP
• 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: 7696936
• MDR Text Key: 114273895
• Report Number: 3004209178-2018-92963
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169507777
• UDI-Public: (01)00643169507777
• 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: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAP
• Device Catalogue Number: MMT-751LNAP
• Device Lot Number: A4751LNAPJ
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 07/17/2018
• Date Device Manufactured: 01/18/2016
• 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 Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 210