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

Model Number MMT-751NAS

Device Problems Invalid Sensing (2293); Device Displays Incorrect Message (2591)

Patient Problems Bruise/Contusion (1754); Blood Loss (2597)

Event Date 12/12/2017

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 the sensor had inaccurate readings that triggered threshold suspend alarm.The customer¿s blood glucose was 95 mg/dl and the sensor glucose was 121 mg/dl at the time of the incident.Since last 3 days the customer had sensor glucose of 80 mg/dl and blood glucose 243 mg/dl and today the sensor glucose was 94 mg/dl and blood glucose was 176 mg/dl and other readings of sensor glucose was 95 mg/dl and blood glucose was 221 mg/dl.Customer also reported that, the blood was visible on the sensor connector.Troubleshooting was done and customer stated that their blood glucose and sensor glucose levels were not in acceptable range.Insulin delivery was suspended due to sensor glucose values.Sensor glucose value that triggered the suspend event was low sensor glucose event.Suspend on low limit in sensor settings was 70 mg/dl.The sensor will not be returned for analysis.

Manufacturer Narrative

Insulin pump passed displacement test.Basic occlusion test, prime test, excessive no delivery test and occlusion test.No error alarm during testing noted.

• Brand Name: 530G INSULIN PUMP MMT-751NAS
• 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: 7152628
• MDR Text Key: 95975925
• Report Number: 2032227-2017-77951
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503717
• UDI-Public: (01)00643169503717
• 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,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAS
• Device Catalogue Number: MMT-751NAS
• Device Lot Number: A4751NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2019
• 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: 62 YR
• Patient Weight: 130