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

Model Number	MMT-723LNAL
Medical Device Problem Codes	Premature Discharge of Battery (1057); Obstruction of Flow (2423); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	06/14/2020
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 were hospitalized due to high blood glucose and diabetic ketoacidosis on june 12, 2020 with blood glucose of 600 mg/dl.The customer was treated with insulin drip and lantus in the hospital.Customer reported that insulin pump had no delivery alarm and unexpected restart alarm.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and delivery accuracy test at 0.08765 inches.The stop current and run current measurement tests are within specification.Device also passed self test and off no power alarm test.The no delivery alarm functions properly during the basic occlusion test and occlusion test.No unexpected no delivery alarm noted during testing.Device was monitored for 2 days.No unexpected suspend anomaly noted.Device alarmed a21 after the battery change due to faulty c13 on i/b.Device uploaded properly using carelink.Device had cracked case at display window corner, scratched reservoir tube window and a missing end cap sticker.The test p-cap and reservoir does lock in place in the reservoir compartment.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAL
• 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: 10182658
• Report Number: 2032227-2020-134877
• Device Sequence Number: 13689995
• Product Code: OYC
• UDI-Device Identifier: 00643169151345
• UDI-Public: (01)00643169151345
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/23/2020

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-723LNAL
• Device Catalogue Number: MMT-723LNAL
• Device Lot Number: A3723LNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Received by Manufacturer: 06/14/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 08/24/2020
• 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 INF SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 29 YR
• Patient Weight: 170