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

Model Number	MMT-551NAP
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/26/2019
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
Customer reported via phone call that the insulin pump was under delivering and they experienced high blood glucose level.Customer¿s current blood glucose level was 382 mg/dl.The customer feels ok to troubleshooting high blood glucose level.Customer reported that they did not contacted their health care professional regarding the high blood glucose event.The customer did not provide any symptoms regarding high blood glucose.The customer was treated for the high blood glucose with injections.The drive support cap appears normal.The customer was neither in the emergency room, nor admitted into hospital as a result of high blood glucose.Based on customer report customer does allege insulin pump was under delivering.The insulin pump and the reservoir was returned for analysis.
Additional Manufacturer Narrative
Device alarmed motor error during basic occlusion test due to faulty force sensor resistor (gold).Unable to perform basic occlusion test, occlusion test, prime test, excessive no delivery test or verify displayable history crc check failed on startup alarm or possible over/under delivery anomaly due to motor error alarm.Motor passed motor test.Additional information has been received which was not included with the initial report.The information has been provided with this report.
Event or Problem Description
It was reported via phone call that the customer's weight has been changed to (b)(6).

• 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: 8407142
• Report Number: 3004209178-2019-65573
• Device Sequence Number: 19326777
• Product Code: OZO
• UDI-Device Identifier: 00643169736047
• UDI-Public: (01)00643169736047
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/30/2019

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-551NAP
• Device Catalogue Number: MMT-551NAP
• Device Lot Number: A6551NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Initial Date Received by Manufacturer: 03/03/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 109