MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-551RNAH PRDGM PINK RECERTI; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-551RNAH
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2019
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¿s mother reported via phone call that the insulin pump had a crack that created a bubble or burst so the customer was not able to read the screen.The customer's blood glucose level was unknown at the time of the incident.The customer also reported that the bottom corner of the insulin pump was cracked, the alarm clock and the ok part was readable.There were some chunks missed.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The device will be returned for analysis.
Additional Manufacturer Narrative
Device received with missing segments/partial display due to cracked and bleeding lcd glass.Unable to perform self-test and displacement test due to missing segments/partial display.Unit had broken battery tube threads.

• Brand Name: PUMP MMT-551RNAH PRDGM PINK RECERTI
• 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: 8618874
• Report Number: 3004209178-2019-98712
• Device Sequence Number: 16216225
• Product Code: OZO
• UDI-Device Identifier: 00643169507920
• UDI-Public: (01)00643169507920
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 06/25/2019

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-551RNAH
• Device Catalogue Number: MMT-551RNAH
• Device Lot Number: A3551RNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Weight: 34