MAUDE Adverse Event Report: MEDTRONIC MINIMED CARELINK PERSONAL; CGA

Model Number MMT-7333

Device Problems Loss of or Failure to Bond (1068); Fluid/Blood Leak (1250); Hole In Material (1293); Inaccurate Delivery (2339); High Test Results (2457)

Patient Problem Hyperglycemia (1905)

Event Date 07/22/2014

Event Type  malfunction  

Event Description

Customer reported that there was a nick in the tubing and that insulin was leaking and dripping out onto the floor.The blood glucose had been running high and he felt he was not receiving the insulin delivery.He also reported that the adhesive would stick to the inserter.No blood glucose reading was given.Nothing further was reported.

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.

• Brand Name: CARELINK PERSONAL
• Type of Device: CGA
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325 121
• Manufacturer Contact: christopher tupper ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764313
• MDR Report Key: 4039310
• MDR Text Key: 4861785
• Report Number: 2032227-2014-10969
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• PMA/PMN Number: P980022
• 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: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7333
• Device Catalogue Number: MMT-7333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/22/2014
• Initial Date FDA Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 120