MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KR 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KR

Device Problems Obstruction of Flow (2423); No Apparent Adverse Event (3189)

Patient Problems Fatigue (1849); Hyperglycemia (1905)

Event Date 06/19/2019

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¿s family member reported via phone call that the customer experienced hyperglycemia and was fatigue.The customer's blood glucose level was 409 mg/dl at the time of the incident and was treated with manual injection.The customer¿s other blood glucose was 403 mg/dl.The customer received a no delivery alarm on the insulin pump.The customer felt okay for troubleshooting.The customer was using insulin pump system within 48 hours of reported high blood glucose event.The customer does not allege that the insulin pump was under delivering.The customer reported that the insulin exited at the quick release.The customer reported that they have a back-up plan available.The device will not be returned for analysis.

• Brand Name: 630G INSULIN PUMP MMT-1715KR 630G
• 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: 8733597
• MDR Text Key: 149163571
• Report Number: 2032227-2019-21179
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00763000173036
• UDI-Public: (01)00763000173036
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715KR
• Device Catalogue Number: MMT-1715KR
• Device Lot Number: HG31FGY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2019
• Date Device Manufactured: 12/14/2018
• 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-332-RSVR, UNOMED INF SET
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 75