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

Model Number	MMT-751LNAB
Medical Device Problem Codes	Computer Software Problem (1112); Device Difficult to Program or Calibrate (1496); Obstruction of Flow (2423); Battery Problem (2885); Power Problem (3010); Patient Device Interaction Problem (4001); Priming Problem (4040)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2020
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
Information received by medtronic indicated that act and up and down buttons were not responding and insulin pump was squirting insulin during priming.Customer also reported that insulin pump received no delivery alarm, unspecified error, battery life was diminished and also stated that sudden power was down without low battery alert and insulin pump hairline was cracked.No harm requiring medical intervention was reported.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device had unresponsive buttons at esc and act due to unlocked lcd keypad connector during visual inspection.Unable to perform operating currents, self test, a21 error test, rewind test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and displacement test or verify prime/fill anomaly, no excessive no delivery/occlusion alarm, unexpected error message, low battery alarm, failed battery alarm and battery out limit due to unresponsive button.No button error alarm during testing.However, keypad flattened button dome switch was found on act, up and down.Pump received with cracked case, cracked battery tube threads and cracked reservoir tube lip.The test infusion set and reservoir does lock into place.(b)(4).

• Brand Name: 530G INSULIN PUMP MMT-751LNAB
• 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: 9956540
• Report Number: 2032227-2020-102767
• Device Sequence Number: 16841534
• Product Code: OZO
• UDI-Device Identifier: 00643169933187
• UDI-Public: (01)00643169933187
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/08/2020

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-751LNAB
• Device Catalogue Number: MMT-751LNAB
• Device Lot Number: A5751LNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 122