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

Model Number MMT-7008A

Device Problems Break (1069); Calibration Problem (2890)

Patient Problems Bruise/Contusion (1754); Hypoglycemia (1912)

Event Date 03/24/2021

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

Svn: (b)(4).Start date of the sensor.Start hour of the sensor.Sensor start missing reason: does not know.Location of sensor insertion: na.Date of sensor alert.Hour of sensor alert.Sensor alert missing reason: does not know (b)(6) 2021 09:54:08 pst (b)(6) per (b)(6): customer reported by e-mail that sensor is presenting calibration not accepted and change sensor alert with less than 3 days customer also reported that when inserted the sensor the insertion site presented a bruise customer also reported a low bg event 23mg/dl we tried to contact the customer without success to troubleshoot complaint was referred to the clinical specialist in order to resolve the issue *no further details given* customer; (b)(6) no rma requested date of report*: (b)(6) 2021.(b)(4).

• 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: 11592465
• MDR Text Key: 252022490
• Report Number: 2032227-2021-129322
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2021
• 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