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); Loss of consciousness (2418)

Event Date 10/10/2022

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.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Information received by medtronic indicated that the customer experienced low blood glucose.The customer was calling due to retainer ring fca.The customer also reported that the customer had a car accident due to low blood glucose.The customer¿s blood glucose at the time of the event was 35 mg/dl.The customer did not experience any symptoms of low blood glucose value.The customer visited emergency room of the hospital for the treatment of low blood glucose on oct 10, 2022.The low blood glucose was treated with iv glucose.It was unknown if the auto mode was activated or not at the time of event.The customer had been using insulin pump within 48 hours of event.No further patient complications were reported.Troubleshooting was successfully performed.The customer will discontinue the use of the device.The product will be returned for analysis.  correction: customer called about the retainer ring field corrective action.Customer had a low of 35mg/dl and got into a car accident due to the low on october 10, 2022 at 15:00.Customer lost consciousness.Paramedics were dispatched.Customer did not go to the emergency room.Customer was treated with intravenous glucose.Customer alleged over delivery.Helpline found time/date was not correct in the pump.Customer later declined replacement pump.Pump was used at the time of the incident.It was unknown if sensor was used.It was unknown if auto mode was used.

• 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: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 7635140379
• MDR Report Key: 16402118
• MDR Text Key: 309940839
• Report Number: 2032227-2023-160873
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 002076300027335801
• UDI-Public: (01)002076300027335801(17)250214(10)HG62GB2
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Device Lot Number: HG62GB2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2022
• Date Device Manufactured: 02/14/2022
• 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: FRN-UNK-RSVR, UNOMED INF SET, OZP-MMT-7020-SNSR
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 77 KG