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); Muscle Weakness (1967)

Event Date 09/24/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer returned pump for an alleged possible over delivery anomaly and low bg found on (b)(6) 2022.Insulin pump passed the displacement test, rewind test, prime/seating test, occlusion test, force sensor test, displacement accuracy test, and self test.Test p-cap and reservoir locked properly into reservoir compartment during testing.No over delivery anomalies noted during testing.Unit successfully downloaded to thus and carelink.Confirmed 6.3 units of normal bolus was delivered on (b)(6) 2022.Several bolus's were programmed, delivered and recorded properly in the insulin pump history.Unable to confirm low bg's.Pump was cut open to perform visual inspection and found¿no evidence of physical or moisture damage on the electronic assembly, motor, or force sensor.The following were noted during visual inspection: keypad overlay peeling, pillowing keypad overlay and label damage (stained).In summary, customers alleged possible over delivery was not confirmed.Pump passed full functional test and displacement accuracy test.No unexpected alarms/alerts noted in pump history.Unable to confirm low bg.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 hypoglycemia with a blood glucose value of 49 mg/dl at the time of the event and the insulin pump off for 2 hrs.The customer experienced symptoms such as weakness and was treated with glucose tab & orange juice.Troubleshooting was performed, and it was unknown that the auto mode feature was active at the time of the event.The customer used the insulin pump within 48 hours of the reported low bg event.No further patient complications were reported; however, the customer will continue the use of the insulin pump.Frn-mmt-332a-rsvr, unomed set.Updated narrative: customer reported via phone call that they were experiencing low blood glucose.Customer blood glucose was 49 mg/dl at the time of event.

• 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: 15984867
• MDR Text Key: 305491321
• Report Number: 2032227-2022-378768
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 000020763000273358
• UDI-Public: (01)000020763000273358(17)241122(10)HG5WL93
• 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: 12/14/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Device Lot Number: HG5WL93
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Initial Date Manufacturer Received: 09/24/2022
• Initial Date FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• 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-MMT-332A-RSVR, UNOMED SET.
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 76 KG