MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523LNAP
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/08/2020
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¿s mother reported via phone call that the customer experiencing high blood glucose.Customer's blood glucose level was over 500 mg/dl at time of incident.Customer had using insulin pump system within 48 hours of reported high blood glucose event and auto mode was active.Customer treated with injection.Customer does not allege insulin pump was under delivering.Customer reported that the insulin pump had button error alarm and no longer working.Customer observe time clock for one minute and time was advances.The insulin pump will returned for analysis.
Additional Manufacturer Narrative
No button error alarm noted during testing.Device had unresponsive buttons due to flattened (creased) esc, up and down buttons dome switch.No unlocked j2/lcd keypad connector noted.Unable to perform rewind test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and displacement test due to unresponsive button.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAP
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 9847044
• Report Number: 3004209178-2020-87548
• Device Sequence Number: 3331459
• Product Code: OYC
• UDI-Device Identifier: 00643169513853
• UDI-Public: (01)00643169513853
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-523LNAP
• Device Catalogue Number: MMT-523LNAP
• Device Lot Number: A4523LNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 04/30/2020
• 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-UNK-RSVR,UNOMED SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 10 YR
• Patient Weight: 26