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 Problem Excess Flow or Over-Infusion (1311)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 12/04/2020

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

The customer reported via phone call that the customer experienced low blood glucose and emergency medical services were called on (b)(6) 2020 with the blood glucose of 65 mg/dl.The customer's current blood glucose was 142 mg/dl.The customer stated she had two episodes of low blood glucose she passed out.The customer stated that she went so low that she drove car and got lost and the police were called emergency medical service came out.The customer was treated with the glucose tablets and glucagon.The customer was alleging that the insulin pump was over delivering, due to low blood glucose event.The customer had been using the insulin pump system within 48 hours of reported low blood glucose event.The insulin pump and reservoir will be returned for analysis.

Manufacturer Narrative

Device passed the functional tests, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and delivery accuracy test at 0.08720 inches.No damage on the motor slide noted.The motor was tested outside of the device and passed.Device received with pillowing keypad overlay and cracked case corner of the belt clip rails near the battery compartment.(b)(4).

• 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: 10989805
• MDR Text Key: 220883984
• Report Number: 2032227-2020-216002
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000190439
• UDI-Public: (01)000000763000190439
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG3RXX0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2019
• 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
• Treatment: UNOMED SET
• Patient Outcome(s): Hospitalization
• Patient Age: 49 YR