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

Model Number MMT-XXX

Device Problems Calibration Error (1078); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2017

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 that they had sensor discrepancies.The customer¿s sensor glucose reading from the reported event was 69 mg/dl while their blood glucose reading was 130 mg/dl.Troubleshooting was performed.The customer stated that insulin delivery was suspended due to a low sensor glucose.The suspend on low limit in the sensor setting was unknown.They were advised to monitor and call back if issues persist.The product 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: 6798099
• MDR Text Key: 82998590
• Report Number: 2032227-2017-37218
• 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: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• 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: 06/05/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 188