MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-723LNAH

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hyperglycemia (1905); Myocardial Infarction (1969); Pneumonia (2011); Renal Failure (2041)

Event Date 05/29/2019

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.

Event Description

The customer reported via phone call that the customer was hospitalized on (b)(6) 2019 due to hyperglycemia, pneumonia, acute kidney failure, and a heart attack.The customer's blood glucose level was 500 mg/dl at the time of the hospitalization.The customer¿s other blood glucose was 74 mg/dl.The insulin pump had a crack on the battery compartment.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The device will be returned for analysis.

Manufacturer Narrative

Device had constant failed battery test alarm after battery insertion due to corroded battery tube.Unable to perform the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime or a33 test, excessive no delivery test, delivery accuracy test, the stop current and run current measurement tests, self test, off no power alarm test and a21 error test due to failed battery test alarm.Unable to verify unexpected no delivery alarm due to failed battery test alarm.Device also had missing segments due to cracked and bleeding lcd glass.Device had minor scratched display window, cracked display window, cracked case at display window corner, cracked battery tube threads and cracked reservoir tube lip.(b)(4).

Manufacturer Narrative

This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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.Incident date has been updated and provided with this report in section b3.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAH
• 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: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 8694559
• MDR Text Key: 147844909
• Report Number: 2032227-2019-15641
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169513884
• UDI-Public: (01)00643169513884
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2022

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-723LNAH
• Device Catalogue Number: MMT-723LNAH
• Device Lot Number: A5723LNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 10/23/2019; 10/18/2022
• Supplement Dates FDA Received: 10/25/2019; 11/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2015
• 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
• Treatment: FRN-UNK-RSVR, UNO INF SET; FRN-UNK-RSVR, UNO INF SET
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 220 KG