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

Model Number	MMT-751NAL
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Obstruction of Flow (2423)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/09/2019
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
The customer reported via phone call that the customer experienced the high blood glucose and the insulin pump was having the keypad issue.The customer's blood glucose was 600 mg/dl, 484 mg/dl.The customer reported that keys were messing up and hard to use.Only the b button works fine, the rest were hard to use and slow to respond.The customer reported that the insulin he pump was not working.The troubleshooting was declined for high blood glucose.The customer was advised to discontinue use of the insulin pump and revert to a back-up plan and the insulin pump will need to be replaced.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received with all no button response due to flattened button dome switch (no crease).The keypad connector on lcd is locked properly during visual inspection.Unable to verify excessive no delivery alarm and perform self test, displacement test, basic occlusion test, occlusion test, prime test, rewind test and excessive no delivery test due to no button response.

• Brand Name: 530G INSULIN PUMP MMT-751NAL
• 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: 8252038
• Report Number: 3004209178-2019-45314
• Device Sequence Number: 1929239
• Product Code: OZO
• UDI-Device Identifier: 00643169736085
• UDI-Public: (01)00643169736085
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-751NAL
• Device Catalogue Number: MMT-751NAL
• Device Lot Number: A6751NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2019
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 03/25/2019
• 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: 50 YR
• Patient Weight: 175