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

Model Number	MMT-751NAB
Medical Device Problem Codes	Mechanical Problem (1384); Environmental Compatibility Problem (2929); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/11/2019
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
The customer reported via phone call that they were hospitalized for high blood glucose.Blood glucose reading was over 600 mg/dl.The customer stated that insulin pump had motor error alarms and they were able to complete rewind process.Customer stated that insulin pump was exposed to high magnetic field at airport scanner.The customer was treated with intravenous drip and manual injections at the hospital.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and delivery accuracy test at 0.0874 inches.No over delivery anomaly or under delivery anomaly noted.The stop current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and a21 error test.Device was monitored for 2 days.No unexpected low battery alarm or unexpected off no power alarm noted.No motor error alarm or displacement anomaly noted during testing.The motor was tested outside of the unit and passed.Device uploaded properly using care link.Device had cracked display window, cracked case at display window corner, broken battery tube threads, scratched reservoir tube window, partially broken reservoir tube lip and a missing end cap sticker.The test p-cap and reservoir does lock in place in the reservoir compartment.(b)(4).

• Brand Name: 530G INSULIN PUMP MMT-751NAB
• 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: 10162171
• Report Number: 2032227-2020-132386
• Device Sequence Number: 3867571
• Product Code: OZO
• UDI-Device Identifier: 00643169404304
• UDI-Public: (01)00643169404304
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 12/06/2020

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-751NAB
• Device Catalogue Number: MMT-751NAB
• Device Lot Number: A2751NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 12/07/2020
• 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-UNK-RSVR,UNOMED INF SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 23 YR
• Patient Weight: 52