MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-723LNAS

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Hyperglycemia (1905); Blurred Vision (2137)

Event Date 06/15/2021

Event Type  Injury  

Manufacturer Narrative

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 reported via phone call that the customer experienced hyperglycemia.Customer stated that the last couple time you have had a bend cannula and it have has caused high blood glucose over 600 mg/dl.The customer current blood glucose level was 111 mg/dl.The customer was assisted with troubleshooting.The customer was treated with insulin pump for high blood glucose.Customer was using insulin pump system within 48 hours of reported high blood glucose event.Customer stated that they did not alleging insulin pump for under delivery.Customer stated that drive support cap was normal.Customer stated that she was outside painting and her vision was blurred and she took a correction bolus and it did not work so about an hour later she took another bolus and so she changed the set and noticed that the cannula was bent in an l shape and that was the second one in the box that has had a bent cannula.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: tricha miles ; 18000 devonshire st.; northridge, CA 91325-1219 ; 7635140379
• MDR Report Key: 12039564
• MDR Text Key: 257403202
• Report Number: 2032227-2021-159685
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000161132
• UDI-Public: (01)000000763000161132
• 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: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723LNAS
• Device Catalogue Number: MMT-723LNAS
• Device Lot Number: A7723LNASJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2021
• Date Device Manufactured: 01/31/2020
• 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 SET
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 63