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 Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unit received with all operating currents within spec and passed functional testing including the rewind, basic occlusion test, occlusion test, prime/compromised force sensor system test, excessive no delivery test, self test, unexpected restart error test and displacement test.Pump passed the delivery accuracy test at 0.08720 inches.The drive support disk was inspected and no anomaly was noted.No excessive no delivery alarms, motor error alarms, external ram crc error alarms or unexpected pump resetting anomaly was noted.The motor was tested outside the device and passed.
Event or Problem Description
The customer reported via phone call that they were hospitalized due to high blood glucose and diabetic ketoacidosis on (b)(6) 2018 with blood glucose of over 600 mg/dl.The customer experienced symptoms such as vomiting.The customer was treated with insulin drip.Customer reported he woke up with the high blood glucose of 585 mg/dl.Customer's blood glucose reading was 88 mg/dl t the time of call.The customer was wearing the insulin pump during the hospitalization.Customer also reported that the insulin pump drive support cap was sticking out.The customer was advised to discontinue use of pump and revert to back-up plan.The insulin pump is being replaced and is expected to return for analysis.

• 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: 7808205
• Report Number: 2032227-2018-16335
• Device Sequence Number: 1469076
• Product Code: OYC
• UDI-Device Identifier: 00613994748713
• UDI-Public: (01)00613994748713
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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
• Report Date (Section B): 08/23/2018

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-723RNAB
• Device Catalogue Number: MMT-723RNAB
• Device Lot Number: A000167986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/23/2018
• 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-RESERVOIRUNO INF SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 51 YR
• Patient Weight: 142