MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722NAH
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	05/08/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The customer reported via phone call that they went hospital due to high blood glucose and diabetic ketoacidosis on unknown date.Customer¿s blood glucose was 446 mg/dl in the hospital.Customer had blood glucose of 40 to 100.Customer had symptoms such as nausea, vomiting abdominal pain, difficulty breathing.Customer was treated that with insulin drip.Customer stated that the buttons were hard to push.Insulin pump was scratched.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and delivery accuracy test at 0.08750 inches.No under delivery anomaly or over delivery anomaly noted.The stop current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and a21 error test.The no delivery alarm functions properly during the basic occlusion test and occlusion test.No unexpected no delivery alarm noted during testing.Device uploaded properly using carelink.Device had a stripped battery cap at coin slot.Device had cracked case at display window corner, cracked battery tube threads, broken belt clip slot, cracked reservoir tube, cracked reservoir tube window, scratched reservoir tube window and cracked reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.(b)(4).

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAH
• Common Device Name: 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
• MDR Report Key: 8626791
• Report Number: 2032227-2019-04704
• Device Sequence Number: 1968675
• Product Code: OYC
• UDI-Device Identifier: 00613994622587
• UDI-Public: (01)00613994622587
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2020

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-722NAH
• Device Catalogue Number: MMT-722NAH
• Device Lot Number: A1722NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-UNK-RSVR, UNOMED UNK
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 55 YR
• Patient Weight: 130