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

Model Number	MMT-751LNAP
Medical Device Problem Codes	Mechanical Problem (1384); Obstruction of Flow (2423); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
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
Customer reported via phone call that the insulin pump had motor error.Customer's blood glucose level was 162 mg/dl and 353 mg/dl.Customer reported that the drive support cap was flush.Advised the insulin pump will need to be replaced.Advised to discontinue use of the insulin pump and revert to backup plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test, rewind, basic occlusion, occlusion, prime/a33 and excessive no delivery test.No excessive no delivery or occlusion alarm noted.No motor error alarm noted.Motor passed motor test.No motor error alarm noted.Motor passed motor test.The drive support disk was inspected and no anomaly noted.(b)(4).

• Brand Name: 530G INSULIN PUMP MMT-751LNAP
• 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: 9003145
• Report Number: 2032227-2019-61210
• Device Sequence Number: 11446875
• Product Code: OZO
• UDI-Device Identifier: 00643169933217
• UDI-Public: (01)00643169933217
• 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): 11/20/2019

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-751LNAP
• Device Catalogue Number: MMT-751LNAP
• Device Lot Number: A5751LNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 155