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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Hyperglycemia (1905); Hypoglycemia (1912); Weakness (2145); Anxiety (2328); Sweating (2444); Shaking/Tremors (2515)

Event Date 07/10/2020

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. 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 experienced low blood glucose. Blood glucose reading was 40 mg/dl. Customer¿s other blood glucose values are 226 mg/dl. Customer was treated with food for their low. Customer had symptoms such as shaking, sweating, anxiety, mental confusion, weakness, and fatigue. The insulin pump will be returned for analysis.

Manufacturer Narrative

Device passed the displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test, sleep current measurement, active current measurement, self test and displacement accuracy test. A water filled reservoir was used during testing. Device was programmed with multiple boluses and monitored. All boluses delivered properly and were listed in the daily history. Device was programmed with multiple basal profiles and monitored. All basal profiles delivered their indicated amounts and were verified in the daily and summary history screens. No delivery anomaly, bolus anomaly or basal anomaly noted during testing. (b)(4).

• 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: 10281119
• MDR Text Key: 199043543
• Report Number: 2032227-2020-147176
• Device Sequence Number: 1
• Product Code: OZO
• 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

• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: HG1KX9Q
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/06/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 01/03/2017
• 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: 07/15/2020 Patient Sequence Number: 1

Treatment

FRN-MMT-332-RSVR, UNOMED INF SET