MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1714K

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

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 05/26/2019

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. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.

Event Description

The customer reported via phone call that the customer was hospitalized due to hypoglycemia on (b)(6) 2019. The customer¿s blood glucose level was 1. 3 mmol/ at the time of incident. The customer was assisted with troubleshooting. The customer did not mention nay treatments and symptoms related to low blood glucose event. Customer was using insulin pump system within 48 hours of reported low blood glucose event. Customer reports they contacted their health care professional regarding the low blood glucose. Customer stated that the insulin pump was not alleging over delivering. Customer stated insulin exited at the quick release. Customer reports basal rates were programmed accurately. Customer reports bolus wizard was programmed accurately. Customer was unable to complete carelink upload. The device will not be returned for analysis.

Manufacturer Narrative

The information that provided in date of event 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. (b)(4).

Event Description

It was reported via phone call the customer had visit to the emergency room due to low blood glucose level and seizure and troubleshooting did not mention about checking quick release, basal or bolus wizard settings.

• Brand Name: PUMP MMT-1714K 630G BLACK MMOL CANADA
• 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: 8657147
• MDR Text Key: 146620429
• Report Number: 2032227-2019-09602
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MMT-1714K
• Device Catalogue Number: MMT-1714K
• Device Lot Number: HG2S57E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 05/31/2019 Patient Sequence Number: 1

Treatment

FRN-UNK-RSVR, UNOMED INF SET