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

Model Number	MMT-723LNAS
Health Effect - Clinical Code	Death (1802)
Date of Event	04/19/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The unit did not have a battery installed when received.Unit passed the displacement test, rewind, basic occlusion test, self test and unexpected alarm error test.The stop (idle) current and run current measurement tests are within specification.Unit also passed off no power alarm test.Unit was unable to prime during prime test.Unable to determine root cause of the prime anomaly due to pump preservation.Unable to perform the occlusion test, excessive no delivery test and the dat test due to prime anomaly.Unit had minor scratched display window, bleeding lcd glass, cracked case at display window corner, broken battery tube threads, cracked belt clip slot, cracked reservoir tube, cracked reservoir tube window, a partially broken reservoir tube lip and a stained end cap sticker.Data analysis: the download history file lists data from (b)(6) 2017 to (b)(6) 2018.There was no data listed for (b)(6) 2018.
Event or Problem Description
It was reported that the customer passed away in an unknown location.The cause of death was unknown.The caller stated that the customer had no illnesses that may have led to the customer's passing.The customer¿s blood glucose was unknown at the time of death.The caller was unsure if the customer was wearing the insulin pump at the time of death.The customer was not using sensors.The caller agreed to return the insulin pump for analysis.
Additional Manufacturer Narrative
Initial report or supplemental report had the incorrect aware date.The correct aware date is (b)(4) 2018.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS
• 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: 7493037
• Report Number: 2032227-2018-02948
• Device Sequence Number: 1339918
• Product Code: OYC
• UDI-Device Identifier: 00613994748898
• UDI-Public: (01)00613994748898
• Combination Product (Y/N): N
• 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): 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-723LNAS
• Device Catalogue Number: MMT-723LNAS
• Device Lot Number: A000167518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 10