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

Model Number	MMT-332A
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	07/31/2018
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
Medtronic legal received information regarding the customer¿s hospitalization from the attorney of the family.The information received on (b)(6) 2020 stated the following - reporter alleges: in or about (b)(6) 2018 the customer began using the insulin pump.On or about the (b)(6) 2018, the customer was found unconscious by emergency medical services and transported to a hospital where they were found to be severely hypoglycemic as a result of an insulin overdose.The customer had suffered hypoglycemic encephalopathy and was hospitalized overnight.The pump did not alarm to alert the customer of the low.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: 10365824
• Report Number: 2032227-2020-157532
• Device Sequence Number: 20317500
• Product Code: FRN
• UDI-Device Identifier: 00643169786547
• UDI-Public: (01)00643169786547(17)210403(10)HG2FB7Q
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/03/2021
• Device Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Device Lot Number: HG2FB7Q
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/04/2020
• 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: FRN-UNK-RSR, MMT923 INFSET
• Patient Age: 53 YR
• Patient Weight: 129