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

Model Number	MMT-551NAP
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/22/2018
Type of Reportable Event	Serious Injury
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
Customer reported via phone call that the insulin pump was not vibrating.Customer's blood glucose value was 270mg/dl.The last couple of days where its been 300mg/dl, 250mg/dl ,275mg/dl.Customer treated with the pump.Customer also believed that his pump is not delivering basals.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 and excessive no delivery test or verify audio or vibrate anomaly and 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-551NAP
• 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: 7238671
• Report Number: 3004209178-2018-48059
• Device Sequence Number: 1146098
• Product Code: OZO
• UDI-Device Identifier: 00643169736047
• UDI-Public: (01)00643169736047
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-551NAP
• Device Catalogue Number: MMT-551NAP
• Device Lot Number: A6551NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Weight: 215