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

Model Number	MMT-751PNAL
Medical Device Problem Codes	Mechanical Problem (1384); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/31/2018
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
The customer reported via phone call that they had experienced high blood glucose and insulin pump received motor error.The customer¿s blood glucose level was 1770 mg/dl.The customer reported that they received a motor error alarm during bolus.Customer was able to successfully clear the alarm.Customer was able to complete pump rewind.The customer reported that the drive support cap was normal.The customer was advised the pump will need to be replaced.The customer was advised to discontinue use of the pump and was advised to refer to back up plan, per health care professional instructions.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Insulin pump passed displacement test, rewind test, basic occlusion test, prime test, excessive no delivery test and occlusion test.No motor error alarm noted.The motor was tested outside of the device and passed.

• Brand Name: 530G INSULIN PUMP MMT-751PNAL
• 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: 8125404
• Report Number: 2032227-2018-70047
• Device Sequence Number: 19240118
• Product Code: OZO
• UDI-Device Identifier: 00643169507333
• UDI-Public: (01)00643169507333
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/11/2019

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-751PNAL
• Device Catalogue Number: MMT-751PNAL
• Device Lot Number: A3751PNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 02/11/2019
• 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-RSR-UNK, UNK-INF SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Weight: 81