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

Model Number MMT-751NAH

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Syncope (1610); Hypoglycemia (1912)

Event Date 04/04/2019

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

Customer called and reported that they received emergency medical assistance due to low blood glucose on (b)(6) 2019 with blood glucose of below 20 mg/dl at the time of the incident.The customer was given intravenous glucose to treat.The customer experienced symptoms such as fainting.The customer was wearing the insulin pump during the incident.The customer was alleging pump over delivery due to unexplained lows.Troubleshooting was not completed.The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751NAH
• 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 ; 8185464805
• MDR Report Key: 8805584
• MDR Text Key: 151549336
• Report Number: 2032227-2019-32184
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169736078
• UDI-Public: (01)00643169736078(10)A6751NAHJ
• 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: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAH
• Device Catalogue Number: MMT-751NAH
• Device Lot Number: A6751NAHJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2019
• Date Device Manufactured: 08/04/2017
• 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): Hospitalization
• Patient Age: 48 YR