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

Model Number	MMT-723RNAL
Medical Device Problem Codes	Premature Discharge of Battery (1057); Mechanical Problem (1384); Connection Problem (2900); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	06/15/2020
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 reported via phone call that they had low blood glucose and ambulance took her to the hospital for a few hours.Blood glucose level at the time of hospital visit was 10 mg/dl.Customer was treated at hospital with intravenous drip.Customer reported that insulin pump received an unexpected restart alarm and motor error alarms.Customer stated that the reservoir did not lock into the insulin pump and they applied tape for security.There was a portion missing from the top of the reservoir compartment.Customer declined to troubleshooting for motor error, unexpected restart alarm and low blood glucose.Insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test, rewind test, prime or a33 test and excessive no delivery test.The stop (idle) current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and a21 error test.No a21 alarm noted during testing.Unable to perform the basic occlusion test, occlusion test and delivery accuracy test due to completely broken off reservoir tube lip.Unable to completed the functional testing or test for motor error alarm due to completely broken off reservoir tube lip.The motor was tested outside of the device and passed.The test p-cap and reservoir will not lock in place in the reservoir compartment due to completely broken off reservoir tube lip.Device also had a missing reservoir tube o-ring, cracked case at display window corner, cracked battery tube threads, cracked belt clip slot and a stained end cap sticker.Device uploaded properly using carelink.
Additional Manufacturer Narrative
Information related to event was incorrect in summary narrative and correct information provided with this report.
Event or Problem Description
It was reported that customer did not treated with a intravenous drip.The customer thinks the paramedics did not remove the insulin pump from body properly resulting in damage to the insulin pump.On (b)(6) 2020 the customer reported that insulin pump received an unexpected restart alarm and continues to experience motor error alarms.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAL
• 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: 10348525
• Report Number: 2032227-2020-155372
• Device Sequence Number: 16808023
• Product Code: OYC
• UDI-Device Identifier: 00643169513129
• UDI-Public: (01)00643169513129
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 10/25/2020

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-723RNAL
• Device Catalogue Number: MMT-723RNAL
• Device Lot Number: A1723RNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 08/12/2020; 10/21/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 08/13/2020; 10/26/2020
• 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: UNOMED INF SET, FRN-MMT-332-RSVR
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 62 YR
• Patient Weight: 200