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 Codes	Hypoglycemia (1912); Seizures (2063)
Date of Event	07/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
The customer's father was reported via phone call that, the customer had low blood glucose and also over delivering the insulin.The blood glucose at the time of the incident was 32 mg/dl.The customer first started getting low blood glucose and on thursday he had 3 seizures, his gotten way lower to 24 mg/dl this morning had to take glucagon and brought him to 50 mg/dl.The customer made changes because he thinks something was wrong with his pump and current blood glucose value as 171 mg/dl.The customer treated low blood glucose with food and glucose tablets.The symptoms related to low blood glucose were sweating, other seizures and loss of consciousness and all happened when he was in bed.For quick recovery the customer's mother did treatments using honey, syrup and glucose gel when he's blood glucose was 24 mg/dl she used glucagon.The customer was using auto mode function at the time of the event.The insulin pump and reservoir will not 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: 10343248
• Report Number: 2032227-2020-155240
• Device Sequence Number: 19704091
• Product Code: FRN
• UDI-Device Identifier: 20763000273358
• UDI-Public: (01)20763000273358(17)221204(10)HG3YZCT
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/04/2022
• Device Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Device Lot Number: HG3YZCT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2020
• Initial Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNOMED-INF SET, OZP-MMT-7020
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 YR
• Patient Weight: 64