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

Model Number	MMT-523LNAL
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/21/2017
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¿s spouse reported via phone call the insulin pump alarmed motor error.The customer¿s blood glucose level was 400 mg/dl at the time of the incident.The customer¿s spouse stated that the insulin pump.The customer¿s parent stated that the drive support cap was normal and that the insulin pump was not exposed to high magnetic fields and was able to complete the rewind process.Customer had experienced a high blood glucose of 400 mg/dl and treated with manual injection.No high blood glucose troubleshooting was performed.The customer¿s spouse was advised to have customer discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump is being replaced and is expected to return for analysis.
Additional Manufacturer Narrative
Insulin pump passed basic occlusion test, occlusion test, prime/compromised force sensor system test, excessive no delivery test, displacement test and rewind test.No motor error alarm or excessive no delivery alarm noted.Motor passed motor test.Insulin pump was received with minor scratched display window, cracked case at display window corners, cracked battery tube threads, cracked reservoir tube lip, cracked case at reservoir tube window corner, cracked reservoir tube window and stained end cap sticker.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAL
• 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: 6981640
• Report Number: 2032227-2017-61973
• Device Sequence Number: 13577602
• Product Code: OYC
• UDI-Device Identifier: 00643169479616
• UDI-Public: (01)00643169479616
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

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-523LNAL
• Device Catalogue Number: MMT-523LNAL
• Device Lot Number: A3523LNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Initial Date Received by Manufacturer: 10/21/2017
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 03/05/2018
• 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: Other
• Patient Age: 61 YR
• Patient Weight: 135