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

Model Number MMT-1715KL

Device Problems Excess Flow or Over-Infusion (1311); No Apparent Adverse Event (3189)

Patient Problem Hypoglycemia (1912)

Event Date 12/28/2020

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

Customer reported via phone call that they experienced low blood glucose level.Customer's blood glucose value was 39 mg/dl at the time of the incident.The customer¿s current blood glucose was 250 mg/dl.Customer has treated with food.Customer has been using insulin pump system within 48 hours of reported low blood glucose event.Customer reported that customer believe insulin pump was over-delivering.The insulin pump will be and reservoir will not returned for analysis.

Manufacturer Narrative

Device was received with a scratched case and a cracked keypad overlay.The test reservoir does lock properly inside the reservoir tube.Device passed the functional tests, including the self test, sleep current measurement, active current measurement, rewind test, prime or seating test, basic occlusion test, occlusion test, force sensor test, displacement test and delivery accuracy test at 0.08670 inches.No rewind anomaly noted.Device primed properly.Device was programmed with multiple bolus deliveries and all bolus delivered properly their indicated amounts and were properly recorded in the daily history.No unexpected occlusions or insulin flow blocked alarm noted during testing.No bolus delivery anomaly or history anomaly noted.No under delivery anomaly or over delivery anomaly noted during testing.(b)(4).

• Brand Name: 630G INSULIN PUMP MMT-1715KL 630G
• 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: 11099975
• MDR Text Key: 224517357
• Report Number: 2032227-2020-222736
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000316655
• UDI-Public: (01)000000763000316655(17)230226
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/26/2023
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG44UQ2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2020
• 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: FRN-UNK-RSVR, UNOMED SET.
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 84