MAUDE Adverse Event Report: MEDTRONIC MINIMED LANCET DEVICE ENLITE SENSERTER; CGM

Model Number MMT-7510

Device Problems Bent (1059); Device Inoperable (1663); Inaccurate Delivery (2339)

Patient Problem Hypoglycemia (1912)

Event Date 02/20/2015

Event Type  malfunction  

Event Description

Customer reported he experienced low blood glucose because he treated with a manual injection that was not his.He gave himself 10 units instead of 1 unit.He had to treat with manual injection because of his reservoirs not working.His blood glucose level dropped and finally got up to 99 mg/dl.Customer reported he had issues with insulin delivery.Customer stated that he found a bent cannula on one infusion set; he was receiving insulin but it was slow.He has another two times he had to push the reservoir with his finger to push it more than the insulin pump would to get insulin to come out.Customer stated that even while disconnected he couldn't get insulin out.He was also having difficulty inserting the sensor.The serter was pulling out the sensor.Customer used scissors to hold the sensor down, but it pulled it out.Last blood glucose is 113 mg/dl.Nothing further 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: LANCET DEVICE ENLITE SENSERTER
• Type of Device: CGM
• 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: 4572518
• MDR Text Key: 15317838
• Report Number: 2032227-2015-08818
• Device Sequence Number: 1
• Product Code: MDS
• 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: 02/20/2015

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-7510
• Device Catalogue Number: MMT-7510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2015
• Initial Date FDA Received: 03/05/2015
• 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: 46 YR
• Patient Weight: 64