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	Power Problem (3010)
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	03/18/2018
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.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
It was reported that the insulin pump had an unexpected battery out limit alarms.Blood glucose value was 41 mg/dl at the time of the incident.No hospitalization or medical attention was needed for the customer.The customer stated they felt sluggish and treated with an insulin syringe.No troubleshooting was performed because this was a past event being reported on and the customer was able to clear the alarm.Nothing will be replaced or returned.
Additional Manufacturer Narrative
Insulin pump passed functional testings including stop current test, run current test, self test, off no power test, unexpected restart error test, seat & rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test.Device was received with normal operating currents and no unexpected battery power loss alarm or low battery alarm noted.Unit was received with cracked case at display window corner, broken battery tube threads and cracked reservoir tube lip.The information provided in concomitant reporting section with the initial report was incorrect.The correct information has been included with this report.(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: 7784894
• Report Number: 2032227-2018-13322
• Device Sequence Number: 173767
• Product Code: OYC
• UDI-Device Identifier: 00643169476493
• UDI-Public: (01)00643169476493
• 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): 11/25/2018

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: A0523RNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 11/17/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 11/25/2018
• 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- INFUSION SET FRN-RESERVOIR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Weight: 165