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

Model Number	MMT-551PNAH
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 customer experienced hyperglycemia.The customer blood glucose level was 520 mg/dl, over 400 mg/dl and 560 mg/dl at the time of incident.The customer was assisted with troubleshooting.The customer was treated with manual injection for high blood glucose level.Customer stated that the insulin pump had crack on the top right hand corner front to the side 1/2 inch, under esc button into the window where 1 inch, battery compartment on the thread part of that opening.Customer decline troubleshooting for high blood glucose.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
Device passed the displacement test and self test.No frozen screen noted during test and time clock advances properly.(b)(4).

• Brand Name: 530G INSULIN PUMP MMT-551PNAH
• 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: 7964576
• Report Number: 2032227-2018-42869
• Device Sequence Number: 16185160
• Product Code: OZO
• UDI-Device Identifier: 00643169507272
• UDI-Public: (01)00643169507272
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2019

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-551PNAH
• Device Catalogue Number: MMT-551PNAH
• Device Lot Number: A3551PNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-UNK-RSVR UNOMED SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Weight: 125