MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715K

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Hypoglycemia (1912); Anxiety (2328); Sweating (2444); Shaking/Tremors (2515)

Event Date 12/12/2018

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 reported via phone call that they experienced low blood glucose.The customer blood glucose level was 48 mg/dl at the time of incident and the current blood glucose of the customer was 230 mg/dl.Customer experienced symptoms such as shaking, sweating, anxiety.The customer was treated with food.Customer had using insulin pump system within 48 hours of reported high blood glucose event.Customer alleging insulin pump was over delivering.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device passed the self test, sleep current measurement, active current measurement, rewind test, prime test, basic occlusion test, occlusion test, force sensor test, displacement test, and the delivery accuracy test.Device was programmed with multiple boluses and monitored.All boluses delivered properly and were listed in the daily history screen.Device then was programmed with multiple basal profiles and monitored.All basal profiles delivered their indicated amounts and were verified in the daily and summary history screens.The units left at the insulin pump display matched properly the units left at test reservoir.No delivery anomaly, bolus anomaly or basal anomaly noted during testing.

• Brand Name: 630G INSULIN PUMP MMT-1715K 630G BLACK MG
• 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 ; 8185464805
• MDR Report Key: 8198884
• MDR Text Key: 131476056
• Report Number: 2032227-2018-79763
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169656840
• UDI-Public: (01)00643169656840(17)180114
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

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 Expiration Date: 01/14/2018
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG1Y956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 03/25/2019
• Supplement Dates FDA Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2017
• 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: 84 YR
• Patient Weight: 122