MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI ; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Chest Pain (1776); Hyperglycemia (1905); Dizziness (2194); Heart Failure (2206)

Event Date 01/23/2019

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.

Event Description

The customer reported via phone call that they were hospitalized due to high blood glucose on (b)(6) 2019 with blood glucose level was 438 mg/dl and 467 mg/dl.Customer experienced symptoms such as chest pains, heart attack, dizziness.The customer other relevant blood glucose level was 30 mg/dl, 500 mg/dl, 200 mg/dl, 392 mg/dl, 304 mg/dl.The customer was treated with intra venous drip.The insulin pump will be returned for analysis.

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 0.08720 inches.

• Brand Name: PUMP MMT-1715KM 630G 3ML BLACK MEDI
• 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: 8303811
• MDR Text Key: 134966763
• Report Number: 3004209178-2019-51591
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169873834
• UDI-Public: (01)00643169873834
• 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: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715KM
• Device Catalogue Number: MMT-1715KM
• Device Lot Number: HG264QY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: 02/14/2019
• Supplement Dates FDA Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2017
• 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
• Treatment: FRN-UNK-RSVR, UNOMED SET
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 144