MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522LNAB
Medical Device Problem Codes	Connection Problem (2900); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	05/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.Unit received with broken reservoir tube lip and missing reservoir tube o-ring.Unit passed the prime/compromised force sensor system test, rewind test and excessive no delivery test.Unable to perform displacement test, basic occlusion test and occlusion test due to broken reservoir tube lip.A test reservoir was installed and did not lock in place due to broken reservoir tube lip.
Event or Problem Description
The customer reported via phone call that their insulin pump was damaged.Customer stated the top rim of the reservoir compartment has partially broken off.Customer stated the reservoir still locks in place.The customer¿s blood glucose level was unknown at the time of the call but mentioned experiencing hypoglycemia and treated with glucose tablets.Customer declined troubleshooting for low reading.The customer was advised to discontinue use of the insulin pump and to revert to the backup plan.The insulin pump was returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAB
• 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: 8572134
• Report Number: 2032227-2019-03699
• Device Sequence Number: 11308263
• Product Code: OYC
• UDI-Device Identifier: 00613994407726
• UDI-Public: (01)00613994407726
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/01/2019

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-522LNAB
• Device Catalogue Number: MMT-522LNAB
• Device Lot Number: A000114252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 119