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 Power Problem (3010); No Apparent Adverse Event (3189)

Patient Problems Cardiac Arrest (1762); Dyspnea (1816); Fever (1858); Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).

Event Description

The customer¿s brother reported via phone call that the customer was hospitalized in emergency room for diabetic ketoacidosis and cardiac arrest on (b)(6) 2019.Customer¿s blood glucose level was 313 mg/dl at the time of incident.Customer stated that the insulin pump received a low battery alert prior to the replace battery alert within 8 hours for 2 times.Customer stated that the battery was not previously used and battery cap not loose, cracked or damaged.Customer stated that the insulin pump was not pushing enough insulin in her body.Customer experienced h1n1 fever, shortness of breath and flu like symptoms.Customer was treated with insulin drip.The insulin pump will be returned for analysis.

Manufacturer Narrative

The information that provided with the initial report was incorrect.The correct information has been included with this report.Additional information has been received which was not included with the initial report.The information has been provided with this report.

Event Description

It was reported that the customer was taken to emergency room for diabetic ketoacidosis and cardiac arrest on (b)(6) 2019.It was also stated that the insulin pump was not pushing enough insulin in the customer's body.It was also reported that the customer before being admitted that the pump's battery was being drained quicker than before and they been constantly changing the battery and figured it was one of the reason why the insulin pump was also not pushing enough insulin in customer body.

Manufacturer Narrative

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 0.08730 inches.However, device trace download analysis confirmed the device alarmed power error 25, power loss alarm, replace battery alert and replace battery now alarm.The power management tool confirmed power error 25, power loss alarm, replace battery alert, replace battery now alarm was triggered when the backup battery loaded voltage was less than 3.5 volts for 4 consecutive hours due to connector resistance electrical board.After disconnecting and reconnecting the internal battery connector on electrical board, the device was monitored and functioned properly.Device received with scratched case, pillowing keypad overlay and minor scratched lcd window.

• 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: 9663470
• MDR Text Key: 177562343
• Report Number: 3004209178-2020-63758
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169656840
• UDI-Public: (01)00643169656840
• 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: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• 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: HG1ELLJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2016
• 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-MMT-332-RSVR, UNOMED SET
• Patient Outcome(s): Hospitalization
• Patient Age: 45 YR
• Patient Weight: 115