MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESERVOIR 3ML MMT-332A; PUMP, INFUSION

Model Number	MMT-332A
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	01/21/2020
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.(b)(4).
Event or Problem Description
It was reported via phone call by the customer's parent that the customer experienced low blood glucose on (b)(6) 2020 with blood glucose of 44 mg/dl at the time of the incident.The customer used food to treat.The customer did not mention any symptoms.The customer was wearing the insulin pump during the incident.The auto mode on the insulin pump was active and automatically adjusting insulin delivery during the event.The customer alleged pump over delivery.Troubleshooting was completed but did not resolve the issue.The insulin pump will be returned for analysis.

• Brand Name: RESERVOIR 3ML MMT-332A
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• MDR Report Key: 9749080
• Report Number: 3004209178-2020-75116
• Device Sequence Number: 13894950
• Product Code: FRN
• UDI-Device Identifier: 00643169786547
• UDI-Public: (01)00643169786547(17)221118(10)HG3XVWX
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/25/2020

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 Expiration Date: 11/18/2022
• Device Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Device Lot Number: HG3XVWX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/25/2020
• 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: Other
• Patient Age: 16 YR
• Patient Weight: 115