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

Model Number	MMT-523NAP
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/25/2017
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.(b)(4).
Event or Problem Description
The customer reported that the insulin pump received multiple pump error alarms.The customer¿s blood glucose level was 73 mg/dl this morning and at 10:55am it was 238 mg/dl.The customer stated that the they did received failed battery test alarm.The customer went into the emergency room to get help with the insulin pump as she could not clear the alarm.The insulin pump was not alarming battery out limit at time of call.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.Unit passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test and dat test at 0.08740 inches.The stop (idle) current and run current measurement tests are within specification.Unit also passed self test, off no power alarm test and error test.No battery out limit alarm, failed battery test alarm, alarm or alarm noted during testing.No unexpected no delivery alarm noted.The no delivery alarm functions properly during the basic occlusion test and occlusion test.No bolus anomaly or basal anomaly noted during testing.Unit had minor scratched display window, debris under the display window, cracked case at display window corner, cracked battery tube threads, cracked reservoir tube, cracked reservoir tube window, a partially broken off reservoir tube lip and a stained end cap sticker.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAP
• 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: 7169359
• Report Number: 3004209178-2018-41269
• Device Sequence Number: 19246527
• Product Code: OYC
• UDI-Device Identifier: 00613994743879
• UDI-Public: (01)00613994743879
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2018

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-523NAP
• Device Catalogue Number: MMT-523NAP
• Device Lot Number: A2523NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Initial Date Received by Manufacturer: 12/25/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 02/07/2018
• 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: Hospitalization
• Patient Age: 56 YR
• Patient Weight: 130