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

Model Number	MMT-751NAB
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	02/07/2019
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.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 they were went to emergency room due to low blood glucose and on (b)(6) 2019 with blood glucose of 30 mg/dl.The customer¿s blood glucose level was 36 mg/dl at the time of incident.The customer's current blood glucose is 164 mg/dl.Customer has been using insulin pump system within 48 hours of reported low blood glucose event.The customer was unconscious as a result of low blood glucose value.The customer treated low blood glucose value with glucagon.Based on customer¿s report customer does not allege over delivery because of low blood glucose.The customer was not recall insulin dripping or squirting from end of set before connecting at their site.The drive support cap appears normal.Customer was able to upload to carelink.Customer was unable to complete carelink upload.The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751NAB
• 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: 8330490
• Report Number: 3004209178-2019-54624
• Device Sequence Number: 13467487
• Product Code: OZO
• UDI-Device Identifier: 00643169736061
• UDI-Public: (01)00643169736061
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 02/12/2019

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-751NAB
• Device Catalogue Number: MMT-751NAB
• Device Lot Number: A6751NABJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 02/12/2019
• 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 INF SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Weight: 88