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

Model Number	MMT-523NAB
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The insulin pump was received with a blank display due to moisture damage at the electronic assembly.Moisture damage was also identified on the motor.The blank display prevented functional testing, which includes: self test, rewind test, displacement test, and verification of a low battery alarm.The following physical damage was noted: minor scratched lcd window, cracked case at the display window corners, cracked lcd window, cracked belt clip slot, cracked battery tube threads, stained end cap sticker, stained address/serial number label and broken reservoir tube lip and missing reservoir tube o ring.A test reservoir was installed and did not lock in place due to completely broken reservoir tube lip.
Event or Problem Description
It was reported via phone call that their insulin pump kept turning off and had to replace the battery frequently.It was also stated there was a broken piece at the reservoir compartment.The customer¿s blood glucose level was 411 mg/dl at the time of the incident, came down to 312 mg/dl and 175 mg/dl after the correction.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump was returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAB
• 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: 7592609
• Report Number: 3004209178-2018-80123
• Device Sequence Number: 19276390
• Product Code: OYC
• UDI-Device Identifier: 00643169202306
• UDI-Public: (01)00643169202306
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2018

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-523NAB
• Device Catalogue Number: MMT-523NAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 06/12/2018
• 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: Other