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	Hyperglycemia (1905)
Date of Event	11/23/2017
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 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 pump was under delivering insulin.The customer¿s current blood glucose level was over 300 mg/dl at time of incident and current blood glucose level was 178 mg/dl.The customer¿s they had issues with pump and had high blood glucose and was treated with manual injection.The customer alleged insulin pump was under delivering and they had been having high blood glucose.Troubleshooting was performed.The customer was the pump will need to be replaced.The customer was to revert to back up plan per health care professional instructions until replacement arrives.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received with intermittent button response due to flattened(escape, up and act ) button dome switch (no crease) and partial unlocked lcd keypad connector noted during visual inspect.Unable to perform all functional testing including the displacement, operating currents, unexpected restart error test, rewind, basic occlusion, occlusion, prime or compromised force sensor system alarm and excessive no delivery test or verify possible under delivery anomaly due to buttons not responding.Device received with cracked battery tube threads, cracked lcd window, minor scratched lcd window, cracked reservoir tube lip, cracked case display window corner, stained end cap sticker, stained address or serial number label, cracked belt clip slot and cracked case reservoir tube window corner.

• 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: 7203941
• Report Number: 3004209178-2018-44342
• Device Sequence Number: 896168
• Product Code: OZO
• UDI-Device Identifier: 00643169507937
• UDI-Public: (01)00643169507937
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/11/2018

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-551RNAL
• Device Catalogue Number: MMT-551RNAL
• Device Lot Number: A3551RNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 98