MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523LNAB
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/21/2017
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
The customer¿s health care professional reported via phone call that the patient¿s blood glucose was high.The customer¿s health care professional reported that the patient was hospitalized to due diabetic ketoacidosis and high blood glucose on (b)(6) 2017.The customer was currently on insulin drip.Patient's blood glucose at time of incident was 550 mg/dl.Patient's current blood glucose was 296 mg/dl.The customer treated for high blood glucose with intravenous drip.Blood glucose value when admitted to hospital was 422 mg/dl.The customer was wearing the pump at time of hospitalization.Based on customer report, customer does not allege pump was under delivering.Customer stated the drive support cap appears normal (slightly indented).The customer declined to complete high blood glucose troubleshooting and moved to bolus wizard troubleshooting.The customer entered 300 mg/dl and has estimated total of 0.0 with no active insulin.The troubleshooting determined that the pump did not make correct calculations based on information entered.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
A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.Unit passed the dat test at 0.08775 inches.All operating currents are within specification.No unexpected low battery or off no power alarms noted.Unit passed functional test including displacement test, rewind, basic occlusion, occlusion, prime/compromised force sensor system, and excessive no delivery alarm test.Unit functioned properly.No delivery anomaly noted during testing.Unit was received with minor scratched lcd window, cracked reservoir tube lip, cracked belt clip slot and broken battery tube thread.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAB
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 7164761
• Report Number: 3004209178-2018-40777
• Device Sequence Number: 16505706
• Product Code: OYC
• UDI-Device Identifier: 00643169479593
• UDI-Public: (01)00643169479593
• 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: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-523LNAB
• Device Catalogue Number: MMT-523LNAB
• Device Lot Number: A3523LNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Initial Date Received by Manufacturer: 12/22/2017
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 02/21/2018
• 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: Hospitalization; Other
• Patient Age: 59 YR
• Patient Weight: 62