MAUDE Adverse Event Report: MEDTRONIC MINIMED CASE ACC-822BK PUMP NGP 3.0ML BLK EN; ACCESSORIES, PUMP, INFUSION

Model Number ACC-822BK

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/08/2021

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

Information received by medtronic stated that the reservoir ring was loose.Customer stated that they were able to lock in place the reservoir when inserted in insulin pump.No harm was required during medical intervention.The insulin pump will not be returned for analysis.

• Brand Name: CASE ACC-822BK PUMP NGP 3.0ML BLK EN
• Type of Device: ACCESSORIES, PUMP, INFUSION
• 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: 12473063
• MDR Text Key: 277390111
• Report Number: 2032227-2021-192777
• Device Sequence Number: 1
• Product Code: MRZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ACC-822BK
• Device Catalogue Number: ACC-822BK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2021
• 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