MAUDE Adverse Event Report: MEDTRONIC MINIMED 530G INSULIN PUMP MMT-751LNAL; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-751LNAL

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 08/25/2017

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

The customer reported via phone call experiencing low blood glucose levels below 30 mg/dl.The customer reported that the paramedics came to treat the low blood glucose.The customer blood glucose level was 92 mg/dl at the time of call.The customer reported having issues with sgvsbg since the pump would say blood glucose levels are 30 mg/dl while the finger stick would say 200 mg/dl.The customer states calling earlier in regards of blood glucose levels and sensor glucose levels and being told to call back if levels are within the difference range.The customer declined to trouble shoot for other alarms and high/low blood glucose levels.The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751LNAL
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• 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: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 7031588
• MDR Text Key: 92032186
• Report Number: 2032227-2017-65807
• Device Sequence Number: 1
• Product Code: OZO
• 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: Patient
• Type of Report: Initial
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAL
• Device Catalogue Number: MMT-751LNAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2017
• 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: 69 YR
• Patient Weight: 274