MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723RNAB
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	10/06/2019
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 hyperglycemia and was hospitalized three times due to over and under doses.The customer high blood glucose level was in range 55 mg/dl to 300 mg/dl.Customer has been experiencing low blood glucose for about 2 months.Customer has been using insulin pump system within 48 hours of reported high blood glucose event.Customer stated the drive support cap appeared normal.Customer does alleged insulin pump was over delivering.Customer treated for using libre continuous glucose monitoring.The insulin pump, reservoir and infusion set will be returned for analysis.
Additional Manufacturer Narrative
Device received with all operating currents within spec and passed functional testing including the rewind test, self-test, a21 error test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test.Also, unit passed the delivery accuracy test at 0.08730 inches.No possible over/under delivery anomaly noted.Device was downloaded and all bolus delivered were found at the carelink pro report.No unexpected prime/fill anomaly noted during testing.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAB
• 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: 9456272
• Report Number: 2032227-2019-131208
• Device Sequence Number: 16684319
• Product Code: OYC
• UDI-Device Identifier: 00643169221567
• UDI-Public: (01)00643169221567
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/21/2020

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-723RNAB
• Device Catalogue Number: MMT-723RNAB
• Device Lot Number: A000290053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2020
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 02/21/2020
• 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-332-RSVR, UNOMED INF SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 78 YR
• Patient Weight: 204