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

Model Number MMT-7040C1

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Unexpected Therapeutic Results (1631); Physical Resistance/Sticking (4012)

Patient Problem Hyperglycemia (1905)

Event Date 01/23/2022

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the user reported inaccurate sensor readings that triggered a threshold suspend.The customer¿s blood glucose was 15.8 mmol/l and sensor glucose was 6.9 mmol/l at the time of the event, the difference was outside the acceptable range.Suspend on low limit in sensor settings was unknown.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 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: 13420847
• MDR Text Key: 295969388
• Report Number: 2032227-2022-108001
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• 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: 01/23/2022
• 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