MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE MMT-7008A; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-7008A

Device Problems Calibration Problem (2890); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2022

Event Type  malfunction  

Event Description

Information received by medtronic the user reported inaccurate sensor readings that triggered a threshold suspend.The customer¿s blood glucose was 236 mg/dl and sensor glucose was 51 mg/dl at the time of the event, the divergence is not within the acceptable range.No harm requiring medical intervention was reported.The sensor will not be returned for analysis.

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.

• Brand Name: SENSOR ENLITE MMT-7008A
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer Contact: tricha miles ; 18000 devonshire st.; northridge, CA 91325 ; 7635140379
• MDR Report Key: 13384321
• MDR Text Key: 287690639
• Report Number: 2032227-2022-106817
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000020763000421292
• UDI-Public: (01)000020763000421292(17)220410(10)J1221P
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/10/2022
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Device Lot Number: J1221P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2022
• Date Device Manufactured: 10/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1