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

Model Number	MMT-551PNAP
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	09/16/2017
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
The customer reported via phone call that the patient¿s blood glucose was low.The customer¿s blood glucose level was 43 mg/dl at the time of the incident.The patient's current blood glucose was 197 mg/dl.The customer reported that she started hallucinating and started seeing lighters, and playing with the curtains.They asked for her daughter and they checked her blood glucose and it was 43 mg/dl and gave her milk.Earlier it was 57 mg/dl.This week she has been low in 60's mg/dl and last night her blood glucose was 63 mg/dl, today she was low again about 67 mg/dl.The patient has treated with food.The drive support cap appears normal (slightly indented).The pump also had a bad battery alarm.It did not alarm after replacing new battery.The customer does believe pump was over delivering insulin.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
The device powered up properly after battery installation.The device was received with all operating currents within specification and passed functional testing including the rewind test, basic occlusion test, occlusion test, prime test, excessive no delivery test, self test, unexpected restart error test, displacement test and displacement accuracy test.No failed battery test, off no power or low battery alarms were noted.The device was received with cracked case at the display window corners, display window, cracked battery tube threads, minor scratched display window and scratched case.

• Brand Name: 530G INSULIN PUMP MMT-551PNAP
• 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: 6912754
• Report Number: 2032227-2017-55461
• Device Sequence Number: 1444007
• Product Code: OZO
• UDI-Device Identifier: 00643169507296
• UDI-Public: (01)00643169507296
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 02/01/2018

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-551PNAP
• Device Catalogue Number: MMT-551PNAP
• Device Lot Number: A3551PNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2017
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 02/02/2018
• 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: 63 YR
• Patient Weight: 185