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

Model Number MMT-332A

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 07/23/2020

Event Type  Injury  

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 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
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 8185464805
• MDR Report Key: 10343248
• MDR Text Key: 200969001
• Report Number: 2032227-2020-155240
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 20763000273358
• UDI-Public: (01)20763000273358(17)221204(10)HG3YZCT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/25/2020
• Date Device Manufactured: 12/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNOMED-INF SET, OZP-MMT-7020
• Patient Outcome(s): Other
• Patient Age: 21 YR
• Patient Weight: 64