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

Model Number MMT-7008A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Calibration Problem (2890); Physical Resistance/Sticking (4012)

Patient Problem Hyperglycemia (1905)

Event Date 11/01/2021

Event Type  malfunction  

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

Information received by medtronic the customer reported inaccurate sensor readings that triggered a threshold suspend.The customer¿s blood glucose was 180 mg/dl and sensor glucose were 84 mg/dl at the time of the event.The difference in value between sensor glucose and blood glucose was out of range.No harm requiring medical intervention was reported.The sensor will not be returned for analysis.

• 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 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: 12879797
• MDR Text Key: 288317163
• Report Number: 2032227-2021-223212
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000020763000421292
• UDI-Public: (01)000020763000421292(17)211130(10)F0321P
• 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: 11/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2021
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Device Lot Number: F0321P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2021
• Date Device Manufactured: 06/03/2021
• 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