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 Inaccurate Delivery (2339)

Patient Problem Hyperglycemia (1905)

Event Date 05/09/2018

Event Type  Injury  

Manufacturer Narrative

Insulin pump 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 0.08710 inches.

Event Description

The customer reported via phone call that the customer was hospitalized due to the high blood glucose level (b)(6) 2018 and the customer was alleging the insulin pump for under delivery of the insulin.The customer¿s blood glucose level at the time of the incident was over 600 mg/dl.The customer¿s current blood glucose level was 240 mg/dl.The customer was treated with insulin.Customer was assisted with the troubleshooting.The reason why customer was alleging the insulin because the basal was not kicking in the insulin pump will be returned for the analysis.

• 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
• MDR Report Key: 7649741
• MDR Text Key: 112702258
• Report Number: 3004209178-2018-86564
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169656840
• UDI-Public: (01)00643169656840(17)180612
• 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: Patient
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/12/2018
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG26RZJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2017
• 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 Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Weight: 200