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

Model Number	MMT-551PNAL
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/07/2018
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.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 the insulin pump alarmed motor error and high blood glucose event.The customer¿s blood glucose level was 489 mg/dl at the time of the incident.The customer stated that the drive support cap was loose.Customer had a high blood glucose of 489 mg/dl and no form of treatment was reported.No high blood glucose troubleshooting was performed.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump is being replaced and is expected to return for analysis.
Additional Manufacturer Narrative
Device passed the displacement test however motor error alarm during prime test due to loose or protruded drive support disc.The motor was tested outside of the device and passed.

• Brand Name: 530G INSULIN PUMP MMT-551PNAL
• 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: 7750156
• Report Number: 3004209178-2018-99440
• Device Sequence Number: 11192659
• Product Code: OZO
• UDI-Device Identifier: 00643169507289
• UDI-Public: (01)00643169507289
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 11/23/2018

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-551PNAL
• Device Catalogue Number: MMT-551PNAL
• Device Lot Number: A3551PNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Received by Manufacturer: 07/07/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 08/05/2018
• Supplement Report FDA Received Date: 11/23/2018
• 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: 77 YR
• Patient Weight: 195