MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522NAB
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2017
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 reported via phone call that the insulin pump had a keypad anomaly after the battery was changed due to a blank display.The customer reported via phone call that the insulin pump had a blank display.Blank display troubleshooting was performed.The customer¿s blood glucose level was 400 mg/dl at the time of the incident.The battery cap was found to be cracked due to wear and tear.The customer stated that the insulin pump was dropped.The battery cap, compartment, and springs were not damaged.The customer was instructed to insert a new battery and the display returned.Button error/keypad anomaly troubleshooting was performed due to an alarm not being able to be cleared.The customer also stated that the insulin being dropped was the significant event leading to the keypad issues.When asked if the time on the clock advanced when monitored for one minute, the customer stated that they were unable to adjust the time.The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Unit power up properly after battery installation.No blank display noted.No button error alarm noted during testing.However, unit had unresponsive all buttons due to corroded keypad traces.Unable to perform operating currents, self-test, unexpected restart error test and displacement test due to unresponsive button.Unit had stripped battery cap coin slot, minor scratched lcd window, cracked battery tube threads, cracked reservoir tube lip, stained address/serial number label and stained end cap sticker.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAB
• 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: 6846389
• Report Number: 2032227-2017-45037
• Device Sequence Number: 19187248
• Product Code: OYC
• UDI-Device Identifier: 00613994402127
• UDI-Public: (01)00613994402127
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 04/19/2018

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-522NAB
• Device Catalogue Number: MMT-522NAB
• Device Lot Number: A5522NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 163