MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522NAB
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/03/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The insulin pump passed the displacement test.However, the unit was unable to perform the prime/compromised force sensor system, excessive no delivery, and occlusion tests due to a motor error alarm.The device was received with a motor error alarm due to a loose/flush drive support disk.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 cracked reservoir tube lip.
Event or Problem Description
The customer reported via phone call that they had no delivery alarm on insulin pump.The customer's blood glucose was high of 598 mg/dl.Troubleshooting did not occur and treatment methods were not mentioned.The insulin pump was returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAB
• 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: 7683107
• Report Number: 3004209178-2018-90826
• Device Sequence Number: 16355856
• Product Code: OYC
• UDI-Device Identifier: 00613994312648
• UDI-Public: (01)00613994312648
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/12/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-522NAB
• Device Catalogue Number: MMT-522NAB
• Device Lot Number: A2522NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 07/12/2018
• 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
• Patient Age: 46 YR
• Patient Weight: 77