MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LWWS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-754LWWS

Device Problems Premature Discharge of Battery (1057); Loss of Data (2903)

Patient Problems Hyperglycemia (1905); Nausea (1970); Vomiting (2144)

Event Date 12/19/2022

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.The insulin pump involved in this event is the paradigm real-time veo insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.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 a high blood glucose level of 580 mg/dl.Patient blood glucose value at the time of the call was 130 mg/dl.  customer currently reporting symptoms related to their high bg like nausea and vomiting.Troubleshooting was performed and it was found that the customer received pump error alarms on the insulin pump, customer was able to clear the alarms but customer was unable to complete the rewind.It was unknown if the customer had continued to use the device.The insulin pump will be returned for product analysis.

Manufacturer Narrative

S/w 3.1e the customer returned the pump for alleged a21 alarm, a47 alarm, rewind anomaly and high bgs on 19-dec-2022.The pump passed the displacement test, rewind test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and dat at 0.0874 inches.No rewind anomaly noted during testing.The stop (idle) current and run current measurement tests are within specification.The pump also passed self test and off no power alarm test.The pump alarmed a21 error after battery insertion during the a21 error test due to faulty c13 on i/b there were multiple a47 alarm in the alarm history screen.A47 alarm due to corrupted history file.The following were noted during visual inspection: no cosmetic damage noted.The test p-cap and reservoir does lock in place in the reservoir compartment.History download was successful using thds and carelink upload was successful.The pump did not have a battery installed when received.The motor was tested outside of the pump and passed.The pump passed all the tests expect the a21 error test.Unable to confirm alleged high bgs.A21 alarm was confirmed.A47 alarm was confirmed.Rewind anomaly was not confirmed.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.The information that provided with the initial report was incorrect.The correct information has been included with this report in b5 section.

Event Description

Customer had received unexpected restart.A cold reset was performed error and displayable history crc check failed on startup error.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LWWS
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; 7635140379
• MDR Report Key: 16059184
• MDR Text Key: 306883259
• Report Number: 2032227-2022-389760
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-754LWWS
• Device Catalogue Number: MMT-754LWWS
• Device Lot Number: A6754LWWSJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1