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

Model Number	MMT-751PNAB
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Patient Device Interaction Problem (4001); Priming Problem (4040)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	11/05/2018
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
Customer reported via phone call that they experienced high blood glucose level of 500 mg/dl.The customer was hospitalized due to non diabetic reason.The customer did not provide any symptoms regarding high blood glucose.The customer was treated for the high blood glucose with intravenous drip.Customer also reported that the up arrow, down arrow and esc buttons.Customer stated that the time was advanced.The drive support cap appears normal.The insulin pump was returned for analysis.
Additional Manufacturer Narrative
Insulin pump passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and dat test at 0.08750 inches.The stop (idle) current and run current measurement tests are within specification.Unit also passed self test, off no power alarm test and a21 error test.No unexpected low battery alarm or unexpected off no power alarm noted during testing.During the occlusion test, the unit recognized the water filled reservoir that was installed in the reservoir compartment.The unit was programmed with a 2.0 unit fill cannula delivery.Then the unit delivered the 2.0 insulin pump properly with water exiting the infusion set.No prime anomaly noted.Insulin pump had intermittent button response on the esc, up arrow and down arrow buttons due to unlocked keypad flex connector on j2 lcd/b.No button error alarm noted.Insulin pump had minor scratched display window, cracked display window, cracked battery tube threads, scratched reservoir tube window and cracked reservoir tube lip.Insulin pump was received without the original battery cap.Unable to verify damage to the battery cap.

• Brand Name: 530G INSULIN PUMP MMT-751PNAB
• 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: 8068218
• Report Number: 2032227-2018-60443
• Device Sequence Number: 1658192
• Product Code: OZO
• UDI-Device Identifier: 00643169507319
• UDI-Public: (01)00643169507319
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/07/2018

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-751PNAB
• Device Catalogue Number: MMT-751PNAB
• Device Lot Number: A3751PNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/07/2018
• 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: UNOMED INF SETFRN-UNK-RSVR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Weight: 230