MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523NAL
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	11/16/2019
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 they experienced high blood glucose and reservoir was not able to lock into place.The customer¿s blood glucose level was 527 mg/dl.Customer stated that the piece was missing at the reservoir.The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received unable to perform the displacement, rewind, basic occlusion, occlusion, prime/a33 and excessive no delivery due to complete broken reservoir tube lip and missing reservoir tube o-ring.The p-cap not locks into the reservoir compartment properly due to completely broken reservoir tube lip noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAL
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 9345640
• Report Number: 2032227-2019-119693
• Device Sequence Number: 3231158
• Product Code: OYC
• UDI-Device Identifier: 00643169202320
• UDI-Public: (01)00643169202320
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 02/06/2020

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-523NAL
• Device Catalogue Number: MMT-523NAL
• Device Lot Number: A000305075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 11/16/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 02/06/2020
• 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: 80 YR
• Patient Weight: 130