MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR MMT-7040C1 GUARDIAN4 5PK OUS 1; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7040C1

Device Problems Unexpected Therapeutic Results (1631); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 12/22/2021

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 user reported inaccurate sensor readings that triggered a delivery suspension.The customer¿s blood glucose was 120 mg/dl and sensor glucose were 54 mg/dl at the time of the event, the difference was outside the acceptable range.Suspend on low limit in sensor settings was reported 70 mg/dl.No harm requiring medical intervention was reported.The sensor will not be returned for analysis.

• Brand Name: SENSOR MMT-7040C1 GUARDIAN4 5PK OUS 1
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• 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: 13103640
• MDR Text Key: 285561945
• Report Number: 2032227-2021-236376
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7040C1
• Device Catalogue Number: MMT-7040C1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2021
• 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