MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751PNAL; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-751PNAL
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/13/2018
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
The customer reported via phone call that the insulin pump had a blank display and also reported that, the insulin pump had unexpected restart alarm.The patient¿s blood glucose level was 308 mg/dl at the time of the incident.Issue was not resolved by troubleshooting.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Device passed displacement test, self test, unexpected restart error test, off no power test and all operating currents tested within the spec range.Device was monitored and tested with no blank display and unexpected restart error test noted.Device received with cracked battery tube thread, corroded battery tube, cracked reservoir tube lip, cracked case near display window corners, cracked on display window, stained end cap sticker and minor scratches on display window noted.

• Brand Name: 530G INSULIN PUMP MMT-751PNAL
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 7361686
• Report Number: 3004209178-2018-58947
• Device Sequence Number: 10773065
• Product Code: OZO
• UDI-Device Identifier: 00643169507333
• UDI-Public: (01)00643169507333
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 06/26/2018

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-751PNAL
• Device Catalogue Number: MMT-751PNAL
• Device Lot Number: A3751PNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 170