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

Model Number MMT-751LNAS

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problem Hypoglycemia (1912)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

The customer's spouse reported via phone call that the customer had a sensor glucose of 125 mg/dl despite a blood glucose of 36 mg/dl.Treatment for the low blood glucose was not mentioned.During troubleshooting it was confirmed that the drive support cap appeared normal.The insulin pump programming was accurate as well.However, the caller confirmed that the insulin pump had been worn through airport scanners.The customer was advised to discontinue use of the insulin pump and revert to their medically prescribed backup plan.The insulin pump will be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751LNAS
• 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: 6989276
• MDR Text Key: 90625644
• Report Number: 2032227-2017-62954
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169507784
• UDI-Public: (01)00643169507784
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAS
• Device Catalogue Number: MMT-751LNAS
• Device Lot Number: A4751LNASJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 240