MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523NAH
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following physical damage on the insulin pump was noted: cracked battery tube thread, broken belt clip slot, broken reservoir tube lip, cracked reservoir tube, cracked case reservoir tube window corners, cracked reservoir tube window, cracked case near display window corners, missing end cap sticker, detached end cap and minor scratches on display window noted.
Event or Problem Description
The customer reported via phone call that their insulin pump was damaged.Customer stated the bottom plastic panel on the motor where the piston is popped out while rewinding.The customer¿s blood glucose level was 164 mg/dl at the time of the incident.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-523NAH
• 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: 7672202
• Report Number: 2032227-2018-08031
• Device Sequence Number: 19175075
• Product Code: OYC
• UDI-Device Identifier: 00643169202313
• UDI-Public: (01)00643169202313
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2018

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-523NAH
• Device Catalogue Number: MMT-523NAH
• Device Lot Number: A000305621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 138