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

Model Number	MMT-751PNAS
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/22/2020
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
The customer was reported via phone call that, the customer had high blood glucose.The blood glucose at the time of the incident was 500 mg/dl.The customer also stated that, the insulin pump had motor error alarm and was able to clear the alarm and rewind the insulin pump.The drive support cap appears to be normal.The customer stated that, the customer had issues with extreme high or low but he has been feeling not well.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 motor error alarm noted.Motor passed motor test.(b)(4).

• Brand Name: 530G INSULIN PUMP MMT-751PNAS
• 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: 10331080
• Report Number: 2032227-2020-153331
• Device Sequence Number: 11625868
• Product Code: OZO
• UDI-Device Identifier: 00643169507357
• UDI-Public: (01)00643169507357
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/30/2020

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-751PNAS
• Device Catalogue Number: MMT-751PNAS
• Device Lot Number: A3751PNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 08/30/2020
• 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-332-RSVR. UNOMED.INF.SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Weight: 73