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

Model Number	MMT-751NAH
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Syncope (1610); Hypoglycemia (1912)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 8805584
• Report Number: 2032227-2019-32184
• Device Sequence Number: 2693820
• Product Code: OZO
• UDI-Device Identifier: 00643169736078
• UDI-Public: (01)00643169736078(10)A6751NAHJ
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-751NAH
• Device Catalogue Number: MMT-751NAH
• Device Lot Number: A6751NAHJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 48 YR