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

Model Number	MMT-551NAL
Medical Device Problem Code	Environmental Compatibility Problem (2929)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	07/25/2020
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 as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
The customer reported via phone call that the paramedics was called on an unknown date due to low blood glucose level with an unknown blood glucose level.The customer had been using the insulin pump system within 48 hours of reported low blood glucose event.The customer was unresponsive to honey so the paramedics treated with glucagon and the customer treated himself with food.The drive support cap appeared normal.The insulin pump was exposed to high magnetic field.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
The information provided with initial report was incorrect.The correct information has been provided with this report.Harm code of loss of consciousness has been removed from this report.(b)(4).
Event or Problem Description
The customer reported via phone call that on (b)(6) 2020 that she had a low bg of 70 mg/dl and required the assistance of emergence medical services.Customer was treated with honey and glucagon.The customer was using the insulin pump system with 48 hours of the reported event.The drive support cap appeared normal.The insulin pump was exposed to high magnetic field.As per troubleshooting no motor position encoder error or motor error alarm present.The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551NAL
• 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: 10372182
• Report Number: 2032227-2020-158793
• Device Sequence Number: 2259220
• Product Code: OZO
• UDI-Device Identifier: 00643169736030
• UDI-Public: (01)00643169736030
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/15/2020

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-551NAL
• Device Catalogue Number: MMT-551NAL
• Device Lot Number: A6551NALJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 10/16/2020
• 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-MMT-326-RSVR, UNOMED INF SET.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Weight: 130