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

Model Number	MMT-723NAB
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	12/30/2017
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 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
It was reported by a diabetes educator that the customer reported that their insulin pump was over delivering.The customer¿s blood glucose level was unknown at the time of the incident, and was at 228 mg/dl at the time of the call.The customer used glucose tablets to treat their lows.The customer had been getting a lot of low events, and the caller noticed missing entries, inaccurate active insulin numbers, and multiple overrides in the pump and the pump reports.Troubleshooting was completed but did not resolve the issue.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Concomitant products were added.
Additional Manufacturer Narrative
Device passed displacement test, rewind test, basic occlusion test, prime test, excessive no delivery test, occlusion test, self test and unexpected restart error test.No bolus anomaly noted during testing.Device passed all operating currents tested within the specific range and passed off no power test.Device passed the delivery accuracy test.(b)(4).

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB
• 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: 7693583
• Report Number: 3004209178-2018-92701
• Device Sequence Number: 16397812
• Product Code: OYC
• UDI-Device Identifier: 00643169693777
• UDI-Public: (01)00643169693777
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MMT-723NAB
• Device Catalogue Number: MMT-723NAB
• Device Lot Number: B6723NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 07/03/2018; 11/20/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 08/22/2018; 11/21/2018
• 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: 12 YR