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 Improper or Incorrect Procedure or Method (2017)

Patient Problems Dehydration (1807); Hyperglycemia (1905); Respiratory Distress (2045); Vomiting (2144)

Event Date 07/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.Pump passed functional testings including displacement test, rewind, basic occlusion test, occlusion test, prime/delivery test and excessive no delivery test.No delivery alarm functioned properly.Drive support disk was inspected and no anomaly was noted.Unit was received with normal operating currents and no unexpected off no power alarm or low battery alarm noted.Unit passed the dat test at 0.08730 inches.Pump was received with cracked case at display window corner, minor scratched lcd window and cracked reservoir tube lip.

Event Description

Customer called and reported that they had high blood glucose on (b)(6) 2017 with blood glucose of 400 mg/dl at the time of the incident.The customer was at 244 mg/dl at the time of the call.The diabetes care manager stated that the customer wears the set for 6 days which is of label use.The customer got hospitalized on (b)(6) 2017 and (b)(6) 2017 due to high blood glucose and believes the pump may have been the cause.They stated that they had not received any no delivery alarms.The customer was at 373 mg/dl and 303 mg/dl at the time of the incidents, and 132 m/dl at the time of this call.The customer used the pump and was given intravenous fluids to treat.The customer experienced symptoms such as vomiting, feeling sick, dehydration, and difficulty breathing.The customer was wearing the insulin pump during the incident.Troubleshooting was completed.The insulin pump will 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: 6769136
• MDR Text Key: 81897381
• Report Number: 2032227-2017-34448
• 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: 08/04/2017

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-751NAB
• Device Catalogue Number: MMT-751NAB
• Device Lot Number: A4751NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2017
• Initial Date FDA Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 31 YR
• Patient Weight: 140