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

Model Number	MMT-551PNAB
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	08/15/2019
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.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
Customer called and reported that they experienced low blood glucose with blood glucose of 54 mg/dl at the time of the incident.The customer used food to treat.The customer did not mention any symptoms.The customer was wearing the insulin pump during the incident.The customer reported the pump was over delivering.Troubleshooting was completed but did not resolve the issue.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device received with all operating currents within specific and passed functional testing including the rewind test, self-test, a21 error test, basic occlusion test, occlusion test, prime or a33 test, excessive no delivery test and displacement test.Also, device passed the delivery accuracy test.No possible over or under delivery anomaly noted.Device was downloaded and all bolus delivered were found at the carelink pro report.No unexpected prime or fill anomaly noted during testing.(b)(4).

• Brand Name: 530G INSULIN PUMP MMT-551PNAB
• 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: 9211803
• Report Number: 2032227-2019-106575
• Device Sequence Number: 17683738
• Product Code: OZO
• UDI-Device Identifier: 00643169507265
• UDI-Public: (01)00643169507265
• 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): 10/30/2019

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-551PNAB
• Device Catalogue Number: MMT-551PNAB
• Device Lot Number: A3551PNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 10/20/2019
• Supplement Report FDA Received Date: 10/31/2019
• 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: Other
• Patient Age: 76 YR
• Patient Weight: 179