MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522RNAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522RNAB
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2017
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.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 that the insulin pump stopped working.They changed the battery and it started alarming and beeping.The customer reported that the insulin pump¿s screen froze to the number 2 after they inserted the battery.The customer¿s blood glucose level was 120 mg/dl.Troubleshooting was performed.They did not see the time clock.The screen was not completely blank.They were advised to insert a new battery.They were advised to monitor the insulin pump for 3 minutes to verify time clock works properly and frozen display, or alarms, do not recur.The customer stated that the screen was still frozen with the number 2 on it.The device will be replaced and returned for analysis due to cosmetic damage.
Additional Manufacturer Narrative
The insulin pump was received with frozen display followed by an unexpected constant audio tone due to moisture damage at electronic assembly.Also received with moisture damage on the keypad, motor and vibrator assembly.Unable to perform all functional testing including the displacement, operating currents, unexpected restart error test, rewind, basic occlusion, occlusion, prime and excessive no delivery test to frozen display.Pump received with minor scratched lcd window, cracked case at the display window corners, cracked case at the reservoir tube window corners, cracked reservoir tube window, cracked belt clip slot, cracked battery tube threads, stained end cap sticker, cracked reservoir tube lip and stained address/serial number label.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522RNAB
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 6791716
• Report Number: 2032227-2017-36524
• Device Sequence Number: 149620
• Product Code: OYC
• UDI-Device Identifier: 00613994408938
• UDI-Public: (01)00613994408938
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 10/11/2017

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-522RNAB
• Device Catalogue Number: MMT-522RNAB
• Device Lot Number: A000115196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 08/14/2017
• Supplement Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 194