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 Hyperglycemia (1905); Irritation (1941)

Event Date 01/14/2020

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 the customer experience hyperglycemia.Customer¿s blood glucose level was 400 mg/dl at time of incident and did a manual bolus.Customer reported that they feel okay to troubleshooting.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.Customer did not allege insulin pump was under delivering.Customer reported that the insulin exited at the quick release.Customer reported that the basal rates were programmed accurately.Customer declined to perform the high-pressure test.Customer stated that the insulin pump had insulin flow blocked alarm multiple times, they replaced the site and the sets, then also getting the same problem.The customer had not tried different cannula lengths.Customer stated that the tubing was not bent or kinked.Customer reported that event was resolved by changing complete set.Customer stated that the cannula site always was sore, irritated and red but heals.Customer stated that the tubing had air bubble and size of air bubbles was inch long in the tubing.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device passed the displacement test, rewind test, prime or 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.The pump was programmed with multiple boluses and monitored.All boluses delivered properly and were listed in the daily history.

• 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: 9609364
• MDR Text Key: 175693169
• Report Number: 3004209178-2020-57636
• 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: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• 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: HG2K5AM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2018
• 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-MMT-332A,UNOMED SET
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 54