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

Model Number	MMT-551PNAP
Medical Device Problem Codes	Mechanical Problem (1384); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2018
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.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.Unit passed rewind, basic occlusion test and displacement test.No motor error alarms were noted.However, unable to prime unit during prime/compromised force sensor system test due to faulty fsr (gold).Unable to perform excessive no delivery test due to prime anomaly.The motor was tested outside the device and passed.
Event or Problem Description
The customer reported via phone call that the insulin pump had a recurring no delivery alarm followed by motor error alarm.Blood glucose level at the time of the incident was 252 mg/dl and treated with correction bolus.The customer stated that the insulin pump was not exposed to high magnetic fields and the drive support cap appears normal.Customer completed troubleshooting and was able to rewind the device.The customer was advised that the insulin pump would be replaced and agreed to return the product for analysis.

• 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: 8576707
• Report Number: 3004209178-2019-92348
• Device Sequence Number: 1809436
• Product Code: OZO
• UDI-Device Identifier: 00643169507296
• UDI-Public: (01)00643169507296
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 05/02/2019

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-551PNAP
• Device Catalogue Number: MMT-551PNAP
• Device Lot Number: A3551PNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 111