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

Model Number	MMT-523NAB
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/10/2018
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 was reported via phone call that, the customer had high blood glucose of 538 mg/dl and customer treated it with a manual shot.Customer also reported that, the whole top of the reservoir compartment is missing and reservoir was not locking in place.Customer declined troubleshooting for the high blood glucose.Troubleshooting determined that, the insulin pump should be replaced.The customer advised to discontinue use of the pump and revert to a back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Insulin ump received with cracked case at the display window corner, broken reservoir tube lip, minor scratched lcd window, stained end cap sticker, stained address or serial number label, cracked belt clip slot, cracked case reservoir tube window corner, cracked lcd window, missing reservoir tube o-ring, cracked reservoir tube window and broken battery tube threads.Unable to perform the displacement, operating currents, unexpected restart error test, rewind, basic occlusion, occlusion, prime or compromised force sensor system alarm and excessive no delivery test due to completely broken reservoir tube lip noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAB
• 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: 7216366
• Report Number: 3004209178-2018-45839
• Device Sequence Number: 16184037
• Product Code: OYC
• UDI-Device Identifier: 00643169077645
• UDI-Public: (01)00643169077645
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/18/2018

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-523NAB
• Device Catalogue Number: MMT-523NAB
• Device Lot Number: A6523NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Initial Date Received by Manufacturer: 01/13/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 01/24/2018
• Supplement Report FDA Received Date: 05/18/2018
• 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: 66 YR
• Patient Weight: 100