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

Model Number	MMT-723RNAH
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The insulin pump was received with missing segment/partial display, problem isolated to lcd board.Unable to perform operating currents, self-test, unexpected restart error test, rewind test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test due to missing segment.The insulin pump had severely scratched lcd window, cracked battery tube threads, cracked reservoir tube lip, broken belt clip slot, scratched reservoir tube window, stained address/serial number label, stained end cap sticker and corroded battery tube.
Event or Problem Description
The customer reported via phone call that they were hospitalized due to diabetic ketoacidosis on (b)(6) 2017 with blood glucose of 700 mg/dl.Customer reported insulin pump was not working, crack on insulin pump and lcd screen not visible.The customer experienced symptoms such as vomiting, diarrhea.The customer was treated with shots.Customer reports they have contacted their healthcare professional regarding the high blood glucose.The customer was not wearing the insulin pump during the hospitalization.Customer was off the device prior to hospitalization for greater than 48 hours.Customer declined trouble shooting because it was a past event and hasn't been on the pump.Customer stated that he went into the hospital he was in for 4 weeks then let go.Customer stated when he was let go he wasn't on the pump and has been on shots the whole remainder of time when he was put back in the hospital.Customer stated he doesn't know what his blood sugar was the first time going into the hospital but the second time he went in his blood sugar was 700.Customer declined trouble shooting for the no delivery.The insulin pump was returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAH
• 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: 7401175
• Report Number: 2032227-2018-02359
• Device Sequence Number: 13630684
• Product Code: OYC
• UDI-Device Identifier: 00613994748720
• UDI-Public: (01)00613994748720
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 04/05/2018

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-723RNAH
• Device Catalogue Number: MMT-723RNAH
• Device Lot Number: A000168687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 04/05/2018
• 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
• Patient Weight: 205