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 Patient Device Interaction Problem (4001)

Patient Problems Hypoglycemia (1912); Blurred Vision (2137); Weakness (2145); Dizziness (2194); Shaking/Tremors (2515)

Event Date 09/06/2020

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 was in emergency room due to hypoglycemia on (b)(6) 2020 with blood glucose value of below 40 mg/dl.The customer was assisted with troubleshooting.The customer stated that the symptoms related to low blood glucose such as shaking, sweating, weakness, blurry vision and dizzy.Customer has been using insulin pump system within 48 hours of reported low blood glucose event.Customer stated that they treated with food, glucose tablets and intravenous insulin.Customer stated that it just dropped when he was taking a nap and did not wake then his wife found her unconscious.Customer also stated that retainer ring was loosed however reservoir able to lock in place when inserted into insulin pump.The insulin pump 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.The test p-cap locks properly in place in the reservoir compartment noted.No loose retainer noted.Device received with scratched case and pillowing keypad overlay.(b)(4).

Manufacturer Narrative

The hospitalization information and treatment provided with initial report was incorrect.The correct information has been provided in this report.(b)(4).

Event Description

The customer required emergency medical services and was given intravenous fluids to treat low blood glucose.

• 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: 10682611
• MDR Text Key: 211425800
• Report Number: 2032227-2020-191433
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG3DNLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2019
• 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: FRN-UNK-RSVR, UNOMED SET
• Patient Outcome(s): Hospitalization
• Patient Age: 40 YR
• Patient Weight: 95