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

Model Number MMT-751LNAH

Device Problems False Reading From Device Non-Compliance (1228); Device Displays Incorrect Message (2591)

Patient Problem Hypoglycemia (1912)

Event Date 10/29/2017

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.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 received emergency medical assistance due to low blood glucose on (b)(6) with blood glucose of 21 mg/dl at the time of the incident.The customer was at 160 m/dl at the time of the call.The customer was given glucose tablets, manual injections, and glucose to treat.The customer experienced symptoms such as unresponsiveness.The customer is unsure if they were wearing the insulin pump during the incident.Troubleshooting was completed and the customer thinks it may be over delivering.Customer reported a battery out limit alarm.The insulin pump will not be returned for analysis.

Manufacturer Narrative

(b)(4).Pump received with the operating currents within spec.And passed the self test, unexpected restart error test, rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test, displacement test, and the dat test at 0.08755 inches.Pump was programmed with multiple boluses and monitored.All boluses delivered properly and were listed in the bolus history screen.Pump then was programmed with multiple basal profiles and monitored.All basal profiles delivered their indicated amounts and were verified in the daily total screen.The units left at pump display matched properly the units left at test reservoir.No delivery anomaly, bolus anomaly, basal anomaly, or battery out limit alarms noted during testing.The belt clip slot was inspected and no damage or anomaly noted.Pump received with cracked minor scratched lcd window and scratched reservoir tube window.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.

• Brand Name: 530G INSULIN PUMP MMT-751LNAH
• 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: 7001811
• MDR Text Key: 91051123
• Report Number: 2032227-2017-63940
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169507753
• UDI-Public: (01)00643169507753
• 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: 12/29/2017

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-751LNAH
• Device Catalogue Number: MMT-751LNAH
• Device Lot Number: A4751LNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2017
• Initial Date FDA Received: 11/03/2017
• Supplement Dates Manufacturer Received: 12/14/2017
• Supplement Dates FDA Received: 12/29/2017
• 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: 58 YR
• Patient Weight: 178