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	No Display/Image (1183); No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/05/2019
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
Customer¿s mother reported via phone call that customer experienced high blood glucose.The customer blood glucose level was over 500 mg/dl and last week blood glucose was 519 mg/dl.Customer treated with insulin pump and manual injection.The customer also reported that the insulin pump was not working.The customer stated that reservoir compartment was crack and reservoir was able to lock in place when inserted into insulin pump.The customer was advice the insulin pump will need to be replaced.Advice to discontinue use of the insulin pump and revert to backup plan per healthcare professional instructions.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received with blank display due to corroded battery tube spring contact and corroded battery tube.Unable to perform all functional testing including the operating currents, a21 error test, rewind, basic occlusion, occlusion, prime and excessive no delivery test due to blank display.Device received with broken reservoir tube lip.

• 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: 9085271
• Report Number: 2032227-2019-65094
• Device Sequence Number: 19464754
• Product Code: OZO
• UDI-Device Identifier: 00643169507296
• UDI-Public: (01)00643169507296
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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?: Yes
• Is this a Product Problem Report?: No
• 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: 09/26/2019
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 10/11/2019
• 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-MMT-326-RSVR, UNOMED SET.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Weight: 123