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

Model Number	MMT-751NAP
Medical Device Problem Codes	Mechanical Problem (1384); Environmental Compatibility Problem (2929); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/17/2020
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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
Customer reported via phone call that they experienced low blood glucose level and insulin pump received motor error alarm and motor position encoder error.Customer stated that they are unable to describe the possible damage to the drive support cap.Customer stated the insulin pump was exposed to magnetic resonance image.Customer stated that insulin pump was not working now.Customer stated that she had a low blood glucose but she was comfortable to continue to troubleshooting.Customer already had a coca cola for her low blood sugar.The device will be returned for analysis.
Additional Manufacturer Narrative
Device received motor error alarm during rewind due to motor encoder signal out of phase.Unable to perform the self-test, a21 error test, displacement test, rewind, basic occlusion test, occlusion test, prime or a33 test and excessive no delivery test due to motor error alarms noted.The information about blood glucose value was not included with initial report.The complete information has been included with this report.
Event or Problem Description
The customer's blood glucose value was 47 mg/dl.

• Brand Name: 530G INSULIN PUMP MMT-751NAP
• 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: 9738013
• Report Number: 3004209178-2020-73542
• Device Sequence Number: 13946781
• Product Code: OZO
• UDI-Device Identifier: 00643169404335
• UDI-Public: (01)00643169404335
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/17/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-751NAP
• Device Catalogue Number: MMT-751NAP
• Device Lot Number: A2751NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 04/17/2020
• 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: 49 YR
• Patient Weight: 54