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

Model Number	MMT-522NAL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The insulin pump was received motor error alarm during the basic occlusion test due to loose/protruded drive support disk.Analysis was unable to perform operating currents, unexpected restart error test, selftest, basic occlusion test, occlusion test, prime test, excessive no delivery test or verify compromised force sensor system alarm due to motor error alarm.The insulin pump had minor scratched lcd window, cracked case at display window corners, cracked battery tube threads, cracked reservoir tube lip , cracked reservoir tube window, cracked case at resevoir tube window corner and missing end cap sticker.(b)(4).
Event or Problem Description
It was reported via phone call that the insulin pump had alarmed a compromised force sensor system.They were changing the infusion set when the alarm occurred.The customer changed the battery and tried to reset it.The customer¿s blood glucose level was 112 mg/dl.Troubleshooting was performed.It was noted that the drive support cap was protruded.The customer was advised to discontinue use of the device and revert to a back-up plan.The customer was advised that the device would be replaced and agreed to return the product for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAL
• 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: 6651694
• Report Number: 2032227-2017-21544
• Device Sequence Number: 19153802
• Product Code: OYC
• UDI-Device Identifier: 00613994372031
• UDI-Public: (01)00613994372031
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 06/19/2017

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-522NAL
• Device Catalogue Number: MMT-522NAL
• Device Lot Number: A4522NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2017
• Initial Report FDA Received Date: 06/19/2017
• 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: 133