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

Model Number	MMT-523LNAL
Medical Device Problem Codes	Failure to Cycle (1142); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2019
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 hospitalized due to hyperglycemia on (b)(6) 2019.Customer¿s blood glucose level value when admitted to hospital 432 mg/dl and over 400 mg/dl.Customer reported that the high blood glucose over delivery of insulin didn't disconnect when priming.Customer treated with manual injection.Customer reported that the insulin pump was not working.Customer stated that the insulin was squirting out during the manual prime process and insulin pump error alarm occurred.Customer was unable to describe any possible damage to the drive support cap.Customer was advised to discontinue use of the device and revert to a back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test and rewind test.Device was unable to prime during prime test and then alarmed a33 during prime test at 4.0 lbs due to faulty force sensor resistor.Unable to complete the functional testing including the basic occlusion test, occlusion test, prime test, excessive no delivery test, delivery accuracy test, the stop current and run current measurement tests, self test, off no power alarm test and a21 error test due to prime anomaly and a33 alarm.Drive support disk was inspected and no anomaly was noted.Device had minor scratched display window, cracked battery tube threads, cracked case at the reservoir tube window corner and cracked reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAL
• 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: 9407474
• Report Number: 2032227-2019-126635
• Device Sequence Number: 19409645
• Product Code: OYC
• UDI-Device Identifier: 00643169932968
• UDI-Public: (01)00643169932968
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/10/2020

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-523LNAL
• Device Catalogue Number: MMT-523LNAL
• Device Lot Number: A5523LNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: 11/30/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 02/10/2020
• 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: Hospitalization
• Patient Age: 84 YR
• Patient Weight: 180