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

Model Number	MMT-723NAH
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 got error alarms on insulin pump.The customer's blood glucose was 468 mg/dl.Customer stated the alarm did not occur right after a battery change.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
The insulin pump passed all functional testing including the displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test.No other alarms noted during test.The insulin pump was received with cracked battery tube threads, cracked lcd window, minor scratched lcd window, cracked reservoir tube lip, cracked case display window corner, missing end cap sticker, stained address label, stained serial number label, broken belt clip slot and cracked case reservoir tube window corner.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH
• 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: 7235348
• Report Number: 3004209178-2018-47810
• Device Sequence Number: 111527
• Product Code: OYC
• UDI-Device Identifier: 00613994743909
• UDI-Public: (01)00613994743909
• 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: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2018

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-723NAH
• Device Catalogue Number: MMT-723NAH
• Device Lot Number: A3723NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 06/22/2018
• 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: 26 YR
• Patient Weight: 235