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

Model Number MMT-551LNAS

Device Problems Break (1069); Inaccurate Delivery (2339)

Patient Problem Hypoglycemia (1912)

Event Date 01/21/2018

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.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 they experienced severe lows and received emergency medical assistance due to low blood glucose on (b)(6) 2018 with blood glucose of 40 mg/dl at the time of the incident.The customer also had lows on (b)(6) and (b)(6) 2018.The customer was given glucagon shots by the school nurse to treat.The customer was most likely wearing the insulin pump during the incident.The customer stated that the pump was broken and not displaying history, so their health care professional took them off the pump.Troubleshooting was not completed as the customer declined.The customer is currently using manual injections to treat their blood glucose.The insulin pump will not be returned for analysis.

Manufacturer Narrative

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.Unit passed their dat test with 0.08795 inches.All operating currents are within specification.No unexpected low battery or off no power alarms noted.Unit passed functional test including displacement test, rewind, basic occlusion, occlusion, prime/compromised force sensor system, and excessive no delivery alarm test.Bolus history and daily totals appear on the main menu screen properly.Unit functioned properly during testing.Unit was received with minor scratched lcd window, cracked reservoir tube lip and cracked battery tube threads.

• Brand Name: 530G INSULIN PUMP MMT-551LNAS
• 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: 7423502
• MDR Text Key: 105239902
• Report Number: 3004209178-2018-63977
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169507739
• UDI-Public: (01)00643169507739
• 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: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551LNAS
• Device Catalogue Number: MMT-551LNAS
• Device Lot Number: A4551LNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2018
• 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 Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 182