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 Hyperglycemia (1905); Pneumonia (2011); Viral Infection (2248)

Event Date 08/10/2021

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the customer passed away in hospital.The customer was hospitalized on (b)(6) 2021 due to covid and pneumonia.The cause of death was covid and pneumonia.The customer¿s blood glucose was 380 mg/dl at the time of death.The customer was not wearing the insulin pump at the time of death.Customer was not using auto mode.The insulin pump will be returned for analysis.The case is reported only for the f.A results.

Manufacturer Narrative

(b)(4).Customer was taken to the er and she was in the icu.On (b)(6) 2021 the customer passed.The pump passed the functional test, 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 the dat at 0.0871 inches.The following were noted during visual inspection: minor scratched display window, scratched case, pillowing keypad overlay, cracked retainer and corroded battery tube.The test p-cap and reservoir does lock in place in the reservoir compartment.History download was successful using thus and carelink upload was successful.The pump did not have a battery installed when received.Please see below for the customer's daily total of all insulin delivered surrounding the date on (b)(6) 2021 and the days prior to that date.On (b)(6) 2021 dailytotalofallinsulindelivered = 89.6, on (b)(6) 2021 dailytotalofallinsulindelivered = 72, on (b)(6) 2021 dailytotalofallinsulindelivered = 111.35, on (b)(6) 2021 dailytotalofallinsulindelivered = 97, on (b)(6) 2021 dailytotalofallinsulindelivered = 35.4, on (b)(6) 2021 dailytotalofallinsulindelivered = 0, on (b)(6) 2021 dailytotalofallinsulindelivered = 0.There was no data listed after on (b)(6) 2021.The pump passed the functional testing.During visual inspection, the pump had a corroded battery tube.

• 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; * 00777-3869
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 7635140379
• MDR Report Key: 13477486
• MDR Text Key: 287811945
• Report Number: 2032227-2022-110258
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000643169656840
• UDI-Public: (01)000000643169656840
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• 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: HG1RRX8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2017
• 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 Age: 69 YR
• Patient Sex: Female
• Patient Weight: 124 KG