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

Model Number	MMT-551NAH
Medical Device Problem Codes	Mechanical Problem (1384); Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2019
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 had motor error alarm.Customer¿s blood glucose was 111 mg/dl.Customer stated that she went into pool with wearing her insulin pump.Customer stated that the drive support cap was normal.Customer was able to clear the alarm.Customer was unable to complete insulin pump rewind.Troubleshooting was performed.Customer was advised that the insulin pump needed to be replaced and to discontinue use of the insulin pump and refer to a back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received with blank display due to moisture damage on the electronics assembly.Unable to perform all functional testing including the operating currents, a21 error test, rewind, basic occlusion, occlusion, prime or a33 and excessive no delivery test or verify motor error alarm due to blank display.Device received with moisture damage motor, vibrator and battery tube assembly.

• Brand Name: 530G INSULIN PUMP MMT-551NAH
• 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: 9070427
• Report Number: 2032227-2019-63204
• Device Sequence Number: 2528995
• Product Code: OZO
• UDI-Device Identifier: 00643169736023
• UDI-Public: (01)00643169736023
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/10/2019

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-551NAH
• Device Catalogue Number: MMT-551NAH
• Device Lot Number: A6551NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Received by Manufacturer: 09/08/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 59