MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722RNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722RNAP
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	06/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pump received with the operating currents within spec.And passed the a21 error test, self test, and the displacement test however, pump alarmed a33 during the basic occlusion test due to loose/protruded drive support disk.Unable to perform the occlusion test, prime/a33 test, dat test, and excessive no delivery test due to a33 alarm.Pump received with cracked reservoir tube lip, cracked battery tube threads, case cracked at the display window corner, minor scratched lcd window, stained end cap sticker, and scratched reservoir tube window.(b)(4).
Event or Problem Description
The customer reported via phone call that they were hospitalized on (b)(6) 2017 at about 2:30 a.M.Due to high blood glucose and diabetic ketoacidosis.The customer stated that when she woke up one morning she felt lethargic and could not breath.The customer¿s blood glucose level at the time of admission was 1204 mg/dl.They were treated with insulin drip, intravenous fluids, and she was switched to manual injections.Their current blood glucose level was 360 mg/dl.Troubleshooting was performed.It was noted that the drive support cap was sticking out.They did not recall pressing the cap while connected.The customer was advised to discontinue use of the device and revert to a back-up plan.The customer was advised that the device would be replaced and agreed to return the product for analysis.
Additional Manufacturer Narrative
Additional information has been received which was not included with the initial report.The additional information has been provided with this report.
Event or Problem Description
It was reported via phone call that the customers weight was (b)(6).

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722RNAP
• 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: 6761149
• Report Number: 2032227-2017-33364
• Device Sequence Number: 16422880
• Product Code: OYC
• UDI-Device Identifier: 00613994409164
• UDI-Public: (01)00613994409164
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/26/2017

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-722RNAP
• Device Catalogue Number: MMT-722RNAP
• Device Lot Number: A000114571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 12/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR