MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751PNAB; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-751PNAB
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/16/2018
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.The device has been returned, but not yet evaluated.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 wife reported via phone call the insulin pump had a frozen display and blank display issue.The customer¿s blood glucose was 302 mg/dl at the time of incident and treated with manual injection.Customer declined high blood glucose troubleshooting.Customer stated that the insulin pump was frozen and the buttons were unresponsive.Customer confirmed that the time is not advancing and the buttons remained unresponsive after battery change.Customer had a blank display that was resolved by battery replacement.It was also mentioned that the customer was hospitalized due to high blood glucose.The customer was advised to discontinue use of pump and revert to back-up plan.The insulin pump is being replaced and is expected to return for analysis.
Additional Manufacturer Narrative
Insulin pump had blank display due to moisture damage on lcd board.Unable to perform idle current test, run current test, self test, off no power test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test due to blank display.Unable to verify frozen screen, time and button keypad anomaly due to blank display.

• Brand Name: 530G INSULIN PUMP MMT-751PNAB
• 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: 7401597
• Report Number: 3004209178-2018-62424
• Device Sequence Number: 61791
• Product Code: OZO
• UDI-Device Identifier: 00643169507319
• UDI-Public: (01)00643169507319
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2018

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-751PNAB
• Device Catalogue Number: MMT-751PNAB
• Device Lot Number: A3751PNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 08/14/2018
• 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: Hospitalization
• Patient Age: 65 YR
• Patient Weight: 200