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	05/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pump was received with no (act, up and escape) button response due to corroded keypad traces.No button error alarm during testing noted.Unable to perform all functional testing including the displacement, operating currents, unexpected error test, rewind, basic occlusion, occlusion, prime and excessive no delivery test due to buttons not responding.No moisture damage on the lcd board, mother board, interface board, rf board, motor, vibrator motor and battery tube assembly during visual inspection.Pump received with cracked case at the display window corner, cracked reservoir tube lip, minor scratched lcd window and cracked battery tube threads.
Event or Problem Description
The customer reported via phone call that the insulin pump had fluid under its lcd screen.The patient's blood glucose at the time of incident is unknown.During troubleshooting the customer stated that the insulin pump was sitting on the shelf in the bathroom during her shower.She noted a small crack in the screen when there was condensation, but the crack did not appear anymore.The customer was advised to discontinue use of the insulin pump and revert to her medically prescribed backup plan.The insulin pump was returned for analysis.
Additional Manufacturer Narrative
The aware date provided with the initial report was incorrect.The correct information has been provided with this report.

• 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: 6826144
• Report Number: 2032227-2017-41717
• Device Sequence Number: 19210348
• Product Code: OZO
• UDI-Device Identifier: 00643169507937
• UDI-Public: (01)00643169507937
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/06/2017

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: 06/19/2017
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 05/22/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 183