MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723RNAH
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 the customer experienced the high blood glucose.The customer¿s blood glucose level was 300, 400 mg/dl.The customer reported that the insulin pump had no delivery alarm.The customer stated that the issue was resolved by changing complete set.The customer was no longer wearing insulin pump because her blood glucose was too high and was making her sick.The troubleshooting was not performed for high blood glucose level.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test.No excessive no delivery alarm noted during test.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAH
• 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: 8526259
• Report Number: 3004209178-2019-83782
• Device Sequence Number: 16740295
• Product Code: OYC
• UDI-Device Identifier: 00643169476578
• UDI-Public: (01)00643169476578
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/27/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-723RNAH
• Device Catalogue Number: MMT-723RNAH
• Device Lot Number: A0723RNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 05/27/2019
• 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: UNOMEDICAL SET, FRN-UNKNOWN-RSVR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Weight: 149