MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723LNAP
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
The customer¿s nurse reported via phone call that the insulin pump would not load and had alarmed a compromised force sensor system.The customer¿s blood glucose level during the incident was 370 mg/dl.The customer was at the hospital.They were hospitalized on (b)(6) 2017 at 12:40 a.M.Due to high blood glucose and diabetic ketoacidosis.The customer¿s blood glucose level at the time of admission was 502 mg/dl.The customer was having trouble with the device and had reset it.The customer had symptoms such as nausea, chest pressure, dry mouth, and frequent urination.They were treated with intravenous therapy and manual injection.The customer was not wearing the device at the time of hospitalization.They were off the device for less than 48 hours prior to the hospitalization.Troubleshooting was performed for the compromised force sensor system.The device will be replaced and returned for analysis.
Additional Manufacturer Narrative
Findings: pump received with normal operating currents and passed the unexpected alarm error test, self test, and the displacement test however, pump alarmed compromised forced sensor during the basic occlusion test due to loose/protruded drive support disk.Unable to perform the occlusion test, primetest, excessive no delivery, and the dat test due to compromised forced sensor alarm.Pump received with cracked reservoir tube lip, case cracked at the display window corner, cracked lcd display window, minor scratched lcd window, missing end cap sticker, and scratched reservoir tube window.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAP
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 6820027
• Report Number: 2032227-2017-40818
• Device Sequence Number: 65565
• Product Code: OYC
• UDI-Device Identifier: 00613994904492
• UDI-Public: (01)00613994904492
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-723LNAP
• Device Catalogue Number: MMT-723LNAP
• Device Lot Number: A000202976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Initial Date Received by Manufacturer: 07/31/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 38 YR
• Patient Weight: 175