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 Problem Inaccurate Delivery (2339)

Patient Problem Hypoglycemia (1912)

Event Date 06/05/2018

Event Type  malfunction  

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

Customer called and reported that their pump was over delivering insulin.The customer had blood glucose of 60 mg/dl at the time of the incident.The customer was at 200 mg/dl at the time of the call.The customer used food to treat.The customer stated their pump used to take 10.5 units when priming and now it takes 6.5 units.The customer was wearing the insulin pump during the incident.Troubleshooting was completed but did not resolve the issue.The customer stated the pump was exposed to an airport body scanner.The insulin pump will be returned for analysis.

Manufacturer Narrative

Insulin pump received with normal operating currents and passed the self-test.Insulin pump failed the displacement test followed by a motor error alarm during rewind due to motor encoder signal out of phase.Unable to perform the basic occlusion test, occlusion test, excessive no delivery test, prime test, and unexpected restart error test or verify possible over delivery anomaly due to motor error alarms.

• 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: 7613225
• MDR Text Key: 111885841
• Report Number: 3004209178-2018-83071
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• 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: 06/20/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2015
• 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: 195