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

Model Number	MMT-751RNAP
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	04/03/2018
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
Customer called and reported that they got hospitalized due to high blood glucose on (b)(6) 2018 with blood glucose of 31 mg/dl at the time of the incident.The customer was admitted due to the low and within 2 hours they went high requiring intravenous insulin and admission into the i.C.U.The customer was at 237, 240, to 268 mg/dl at the time of the call.The customer was wearing the insulin pump during the incident.Troubleshooting was completed but did not resolve the issues.The customer had to change the reservoir because of air bubbles and could see air bubbles in the set.The customer was having sensor calibration issues as well as sensor glucose versus blood glucose differences.The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751RNAP
• 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: 7428227
• Report Number: 3004209178-2018-64944
• Device Sequence Number: 19326900
• Product Code: OZO
• UDI-Device Identifier: 00643169507999
• UDI-Public: (01)00643169507999
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 04/13/2018

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-751RNAP
• Device Catalogue Number: MMT-751RNAP
• Device Lot Number: A3751RNAPJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2018
• Initial Report FDA Received Date: 04/13/2018
• 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: MMT-XXX; UNOMEDICAL
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 70 YR
• Patient Weight: 155