MAUDE Adverse Event Report: MEDTRONIC MINIMED OTHER; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-XXX

Device Problems False Reading From Device Non-Compliance (1228); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2017

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

The customer reported via phone call the sensor had inaccurate readings that triggered threshold suspend alarm.The customer¿s blood glucose was 104 mg/dl and the sensor glucose was 72 mg/dl at the time of the incident.The customer¿s blood glucose at the time of the call was 235 mg/dl.The customer was informed that their blood glucose and sensor glucose levels were not in acceptable range.The customer was sent a new sensor.The sensor will not be returned for analysis.

• Brand Name: OTHER
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• 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: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 6555549
• MDR Text Key: 74898358
• Report Number: 2032227-2017-20556
• Device Sequence Number: 1
• Product Code: MDS
• 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: Patient
• Type of Report: Initial
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-XXX
• Device Catalogue Number: MMT-XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR