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

Model Number MMT-551NAS

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

Patient Problem Hyperglycemia (1905)

Event Date 12/09/2017

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

The customer reported via phone call that they were hospitalized due to low blood glucose on (b)(6) 2017 with blood glucose of 30 mg/dl. The customer experienced symptoms such as unresponsiveness. The customer was treated with glucose, food and dextrose. The customer was wearing the insulin pump during the hospitalization. The customer¿s blood glucose level was low 50 mg/dl and then after dinner it went up to 280 mg/dl and current blood glucose level was 146 mg/dl. The drive support cap was normal. The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551NAS
• 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: 7144568
• MDR Text Key: 95718020
• Report Number: 2032227-2017-76562
• Device Sequence Number: 1
• Product Code: OZO
• 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: Patient
• Type of Report: Initial
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MMT-551NAS
• Device Catalogue Number: MMT-551NAS
• Device Lot Number: A4551NASJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 12/22/2017 Patient Sequence Number: 1