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

Model Number	MMT-723LNAB
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
The customer reported via phone call the insulin pump had multiple motor error alarms.The customer¿s blood glucose level was 328 mg/dl at the time of the incident and declined high blood glucose troubleshooting.The customer stated that the drive support cap was normal and that the insulin pump was not exposed to high magnetic fields.Customer reported a motor position encoder error.The customer was advised to 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
Pump alarmed motor error during rewind due to motor encoder signal out of phase.Unable to perform the displacement test, rewind, basic occlusion test, occlusion test, prime test and excessive no delivery test or verify the motor position encoder error alarm due to motor error alarms.Pump received with minor scratched lcd window, cracked case at the display window corners, cracked lcd window, cracked belt clip slot, broken battery tube threads, stained end cap sticker, stained address/serial number label and cracked reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAB
• 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: 7425940
• Report Number: 3004209178-2018-64441
• Device Sequence Number: 2053192
• Product Code: OYC
• UDI-Device Identifier: 00643169478565
• UDI-Public: (01)00643169478565
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-723LNAB
• Device Catalogue Number: MMT-723LNAB
• Device Lot Number: A4723LNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 250