MAUDE Adverse Event Report: MEDTRONIC MINIMED 10-PACK OVERTAPE ASSEMBLY, ENLITE; TAPE AND BANDAGE, ADHESIVE

Model Number 7005739-002

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hyperglycemia (1905)

Event Date 07/13/2018

Event Type  Injury  

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

Medtronic received information that battery cap cracked/damaged occurred.There was an allegation of hyperglycemia as a result of this event.

• Brand Name: 10-PACK OVERTAPE ASSEMBLY, ENLITE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• 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: 14903128
• MDR Text Key: 295230395
• Report Number: 2032227-2022-264717
• Device Sequence Number: 1
• Product Code: KGX
• 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: Other
• Type of Report: Initial
• Report Date: 07/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 7005739-002
• Device Catalogue Number: 7005739-002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2018
• Initial Date FDA Received: 07/04/2022
• 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 Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 79 KG