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

Model Number MMT-1715K

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

Patient Problems Purulent Discharge (1812); Hyperglycemia (1905); Hypoglycemia (1912); Unspecified Infection (1930); Pain (1994)

Event Date 09/18/2018

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

Customer reported via phone call that they experienced high blood glucose level of 454 mg/dl and low blood glucose level of 43 mg/dl.Customer¿s current blood glucose level was 307 mg/dl.The customer feels ok to troubleshooting high blood glucose level.Customer treated their low blood glucose with eating 2 yogurts, juice, and a granola bar.Customer refused to troubleshooting for low blood glucose level.Customer reported that they did not contacted their health care professional regarding the high blood glucose event.The customer did not provide any symptoms regarding high blood glucose.The customer was treated for the high blood glucose with manual injections.The drive support cap appears normal.The customer was neither in the emergency room, nor admitted into hospital as a result of high blood glucose.Based on customer report customer does not allege insulin pump was under delivering.The insulin pump was not returned for analysis.

• Brand Name: 630G INSULIN PUMP MMT-1715K 630G BLACK MG
• 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: 7930912
• MDR Text Key: 122523848
• Report Number: 2032227-2018-36620
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00763000090197
• UDI-Public: (01)00763000090197(17)210523
• 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
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/23/2021
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG2KD0V
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2018
• Date Device Manufactured: 05/24/2018
• 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-RSVR 332, UNOMED INF SET, MMT-7020-SNSR
• Patient Age: 40 YR
• Patient Weight: 62