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

Model Number MMT-751NAB

Device Problem Occlusion Within Device (1423)

Patient Problems Purulent Discharge (1812); Hyperglycemia (1905)

Event Date 05/10/2017

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 being hospitalized from (b)(6) 2017 with high blood glucose of 600 mg/dl and diabetic ketoacidosis.The customer experienced symptoms such as dizziness and nausea.She was taken to the hospital by the ems and admitted into the icu.She was treated with insulin drip.The customer was wearing the insulin pump at the time of the incident.The customer stated that after she was discharged from the hospital, she found that the cannulas were getting occluded.The customer had signs of site infection such as redness, swelling, and pus discharge and stated she had been experiencing high blood glucose up to 600 mg/dl.The customer stated she had the site infection for about 3 weeks.Blood glucose at the time of the call was 466 mg/dl.The customer treated with the insulin pump and metformin.The customer was instructed about the proper insertion technique and advised to contact the doctor for diagnose and treatment.Troubleshooting for high blood glucose was not performed.The insulin pump or infusion sets will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751NAB
• 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: 6624401
• MDR Text Key: 77189547
• Report Number: 3004209178-2017-53951
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503670
• UDI-Public: (01)00643169503670
• 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: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAB
• Device Catalogue Number: MMT-751NAB
• Device Lot Number: A4751NABJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2017
• 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: 26 YR
• Patient Weight: 161