MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551RNAL PRDGM CLEAR RECERT; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-551RNAL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 the insulin pump would not exit the preparing to prime screen.The customer¿s blood glucose level was unknown at the time of the incident.The customer mentioned that they have been having high blood glucose for the past few days but declined to troubleshoot for the high readings.The customer stated that they were unable to complete a set change.The customer was advised to hold down the act button until receiving a second series of beeps and/or numbers appear on the display.The customer stated that they did not receive the beeps nor did the numbers appear on the screen.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
The insulin pump passed all functional testing including the displacement, operating currents, rewind, basic occlusion, occlusion, prime and excessive no delivery test.No prime and fill anomaly and no audio and vibrate anomaly noted during test.The insulin pump was received with cracked case at the display window corner, cracked reservoir tube lip, minor scratched lcd window and cracked battery tube threads.

• Brand Name: 530G INSULIN PUMP MMT-551RNAL PRDGM CLEAR RECERT
• 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: 6714123
• Report Number: 2032227-2017-28595
• Device Sequence Number: 13837688
• Product Code: OZO
• UDI-Device Identifier: 00643169507937
• UDI-Public: (01)00643169507937
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/01/2017

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-551RNAL
• Device Catalogue Number: MMT-551RNAL
• Device Lot Number: A3551RNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 142