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	06/05/2017
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 mother reported via phone call that the customer had a high blood glucose of 600 mg/dl.The customer treated via manual insulin injection.Prior to the high blood glucose, the insulin pump would failed to delivery insulin during bolus attempts.The insulin pump had alarmed with multiple motor error alarms.During troubleshooting it was confirmed that the drive support cap appeared normal.The insulin pump was able to successfully rewind as well.However, the customer was advised to discontinue use of the insulin pump and revert to their medically prescribed back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Findings: pump unable to prime during prime test due to faulty force sensor resistor.Pump passed idle current test, run current test, self test, off no power test, unexpected alarm error test, basic occlusion test, displacement test and rewind test.Unable to perform occlusion test and excessive no delivery test due to prime anomaly.Unable to verify excessive no delivery alarm due to prime anomaly.No motor error alarm noted.Motor passed motor test.Pump received with severely scratched display window, bleeding lcd glass, cracked case at display window corners, cracked reservoir tube lip, cracked reservoir tube and missing end cap sticker.

• 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: 6678643
• Report Number: 2032227-2017-24975
• Device Sequence Number: 43314
• Product Code: OYC
• UDI-Device Identifier: 00613994743848
• UDI-Public: (01)00613994743848
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2017

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: A3523NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Initial Date Received by Manufacturer: 06/06/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 09/20/2017
• 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: 12 YR
• Patient Weight: 77