MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAH; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-551NAH

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

Patient Problem Hyperglycemia (1905)

Event Date 11/25/2017

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

It was reported on social media and in a call by the customer's parent that the customer would have extreme highs and lows of 27 to 600 mg/dl, every time they changed their set.The pump also gave the customer insulin using the bolus wizard even though the pump was showing zero units should have been pumped.The customer was wearing the insulin pump during the incident.Troubleshooting was not completed.Customer was dissatisfied with the pump and customer service.The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551NAH
• 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: 7106633
• MDR Text Key: 94471050
• Report Number: 2032227-2017-72019
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503632
• UDI-Public: (01)00643169503632
• 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: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAH
• Device Catalogue Number: MMT-551NAH
• Device Lot Number: A4551NAHJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2017
• 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 Age: 10 YR