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

Model Number	MMT-751LNAH
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
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
The customer reported via phone call that the insulin pump received multiple pump error alarms.The customer¿s blood glucose level was unknown at the time of incident.Customer stated that the insulin pump had virtual watch dog alarm, motion sensor test failure and motor error alarm.Customer declined for troubleshooting.Customer was able to clear the alarms, however unable to complete insulin pump rewind.The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and was recommended to refer back up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Insulin pump alarmed motor error during rewind due to motor encoder signal out of phase.Unable to perform the displacement test, rewind, basic occlusion test, occlusion test, prime test and excessive no delivery test or verify a35 alarm and e/a alarm due to motor error alarms.

• Brand Name: 530G INSULIN PUMP MMT-751LNAH
• 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: 8860752
• Report Number: 2032227-2019-41315
• Device Sequence Number: 2000330
• Product Code: OZO
• UDI-Device Identifier: 00643169933194
• UDI-Public: (01)00643169933194
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-751LNAH
• Device Catalogue Number: MMT-751LNAH
• Device Lot Number: A5751LNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 52