MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523RNAP
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	04/20/2020
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
Information received by medtronic indicated that the patient had high blood glucose levels, diabetic ketoacidosis and hospitalization.Customer's blood glucose level was over 600 mg/dl.Troubleshooting was performed.Customer treated their high blood glucose via iv fluid and medical daily insulin.Customer advised the insulin pump was taken off of the patient by the hospital and the battery died which resulted in the insulin pump being off.Customer was advised to change out their entire infusion set, reservoir, insulin and treat their blood glucose via healthcare provider's instructions.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 0.08730 inches.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.Device powered up properly after the test battery was installed.Device was monitored for 4 days.No blank display noted.Device uploaded properly using care link.Device had cracked battery tube threads, cracked case at the reservoir tube window corner 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 REVEL INSULIN INFUSION PUMP MMT-523RNAP
• 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: 10006309
• Report Number: 2032227-2020-111027
• Device Sequence Number: 3387108
• Product Code: OYC
• UDI-Device Identifier: 00643169513082
• UDI-Public: (01)00643169513082
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/17/2020

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-523RNAP
• Device Catalogue Number: MMT-523RNAP
• Device Lot Number: A1523RNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 06/18/2020
• 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: UNOMED SET FRN-MMT-326-RSVR
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 71 YR