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

Model Number	MMT-751PNAL
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/26/2018
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.The device has been returned, but not yet evaluated.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 experienced the hyperglycemia.Customer¿s blood glucose level was 408 mg/dl at the time of incident.Customer¿s current blood glucose is 126 mg/dl.Customer also reported that insulin pump had alarmed compromised force sensor system.The customer stated that they were not able to complete the rewind.The customer stated that customer was neither in emergency room, nor admitted into hospital as a result of high blood glucose.The customer did not experiences any symptoms related to the high blood glucose.Customer had using insulin pump system within 48 hours of reported high blood glucose event.Based on customer report customer does not allege pump was under delivering.Troubleshooting was done for high blood glucose under delivery.The customer treated for high blood glucose with the insulin pump.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed displacement test.However device alarmed motor error during basic occlusion test due to loose or protruded drive support disk.Unable to perform occlusion test, prime test, excessive no delivery test.

• Brand Name: 530G INSULIN PUMP MMT-751PNAL
• 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: 7947123
• Report Number: 2032227-2018-39579
• Device Sequence Number: 13645668
• Product Code: OZO
• UDI-Device Identifier: 00643169507333
• UDI-Public: (01)00643169507333
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/16/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-751PNAL
• Device Catalogue Number: MMT-751PNAL
• Device Lot Number: A3751PNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 01/16/2019
• 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 MODEL UNKNOWN, UNOMEDICAL - INFUSION SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Weight: 86