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

Model Number	MMT-523NAB
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/08/2020
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
It was reported via phone call by the customer's spouse that the customer got hospitalized due to high blood glucose with blood glucose in the 491 to 550 mg/dl range at the time of the incidents.The caller did not mention how the customer was treated.The caller did not mention any symptoms.The customer was wearing the insulin pump during the incidents.The caller reported the customer was getting no delivery alarms.The customer's pump settings had been regularly adjusted by their health care professionals, set changes were performed, and the insulin vial was changed, but the customer was still having highs.The customer would only go lower using manual injections.Troubleshooting was not completed as the caller declined.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAB
• 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; * 00777-3869
• MDR Report Key: 10050676
• Report Number: 2032227-2020-117238
• Device Sequence Number: 19059545
• Product Code: OYC
• UDI-Device Identifier: 00643169507166
• UDI-Public: (01)00643169507166
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/13/2020

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-523NAB
• Device Catalogue Number: MMT-523NAB
• Device Lot Number: B4523NABJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 05/13/2020
• 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-326-RSVRUNOMED SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 81 YR
• Patient Weight: 230