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

Model Number	MMT-523RNAH
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/21/2017
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
Customer's spouse reported via phone call that customer experienced high blood glucose level of 521 mg/dl.The customer treated with manual injection.Customer's blood glucose value was 521 mg/dl at the time of the call.Customer declined to troubleshoot for high readings.Customer's spouse also reported that the insulin pump alarmed no delivery and motor error alarm.The customer stated that the drive support cap was normal and that the insulin pump was not exposed to high magnetic fields and was able to complete the rewind process.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump is being replaced and is expected to return for analysis.
Additional Manufacturer Narrative
Motor error alarm during rewind due to motor encoder signal out of phase.Unable to perform occlusion test, prime test, excessive no delivery test, displacement test or verify excessive no delivery alarm due to motor error alarm.Pump received with minor scratched display window, cracked case at display window corners, broken battery tube threads, cracked reservoir tube lip, cracked case at reservoir tube window corner and cracked reservoir tube window.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAH
• 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: 6981763
• Report Number: 2032227-2017-61991
• Device Sequence Number: 684699
• Product Code: OYC
• UDI-Device Identifier: 00613994918642
• UDI-Public: (01)00613994918642
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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-523RNAH
• Device Catalogue Number: MMT-523RNAH
• Device Lot Number: A000205315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Initial Date Received by Manufacturer: 10/21/2017
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Weight: 106