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

Model Number	MMT-723RNAP
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	10/03/2018
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
It was reported that the customer received emergency medical assistance due to low blood glucose with blood glucose of 20 mg/dl at the time of the incident.The customer was given a glucagon shot to treat.The caller did not mention any symptoms.The customer was wearing the insulin pump during the incident.The customer received a compromised force sensor system alarm.Troubleshooting was not completed but the pump was able to rewind.No further information was provided.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device alarmed a33 during the prime test due to due to faulty force sensor resistor.Unable to perform the occlusion test, excessive no delivery test and the delivery accuracy test due to a33 alarm.All operating currents are within specification.Off no power alarm functions properly.Device passed the displacement test, rewind, basic occlusion test, self test and a21 error test.Device uploaded properly using care link.Device had minor scratched display window, a small crack on the display window, cracked case at display window corner, cracked battery tube threads, broken belt clip slot, scratched reservoir tube window, cracked reservoir tube lip and a stained end cap sticker.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAP
• 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: 7948654
• Report Number: 2032227-2018-39683
• Device Sequence Number: 2338562
• Product Code: OYC
• UDI-Device Identifier: 00613994904393
• UDI-Public: (01)00613994904393
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 07/18/2019

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-723RNAP
• Device Catalogue Number: MMT-723RNAP
• Device Lot Number: A000204715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 07/18/2019
• 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 UNKNOWN INFUSION SET FRN UNKNOWN RESERVOIR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 20 YR
• Patient Weight: 140