MAUDE Adverse Event Report: MEDTRONIC MINIMED CLIP ACC-1601 PUMP NGP 23L; ACCESSORIES, PUMP, INFUSION

Model Number ACC-1601

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/03/2021

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 indicated that the insulin pump was damaged.The customer reported that the retainer ring was cracked.Customer stated that reservoir was able to lock in the place.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

• Brand Name: CLIP ACC-1601 PUMP NGP 23L
• 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: 12447909
• MDR Text Key: 271931527
• Report Number: 2032227-2021-191227
• Device Sequence Number: 1
• Product Code: MRZ
• 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: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ACC-1601
• Device Catalogue Number: ACC-1601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2021
• 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
• Patient Age: 60 YR
• Patient Weight: 75