MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715 PARADIGM INSULIN PUMP; PUMP, INFUSION, INSULIN

Model Number MMT-715WWS

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

Patient Problems Hyperglycemia (1905); Blood Loss (2597)

Event Date 08/31/2020

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

Event Description

It was reported that customer went to emergency room for high blood glucose.Customer stated they removed cannula and there were blood in the cannula and little in adhesive.Customer performed high pressure test and it was pass.The insulin pump will not be returned for analysis.

• Brand Name: MMT-715 PARADIGM INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 8185464805
• MDR Report Key: 10513088
• MDR Text Key: 206276431
• Report Number: 2032227-2020-174833
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 000000763000161064
• UDI-Public: (01)000000763000161064
• Combination Product (y/n): N
• Reporter Country Code: LE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-715WWS
• Device Catalogue Number: MMT-715WWS
• Device Lot Number: B3715WWSJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2020
• Date Device Manufactured: 10/05/2018
• 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-UNK-RSVR, UNOMED INF SET
• Patient Outcome(s): Other