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

Model Number	MMT-522LNAP
Medical Device Problem Codes	Mechanical Problem (1384); Obstruction of Flow (2423); Date/Time-Related Software Problem (2582); Power Problem (3010); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit received with motor error alarms during rewind due to motor encoder signal out of phase.Unable to perform operating currents, self-test, a21 error test, rewind test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and displacement test or verify no excessive no delivery/occlusion alarm and failed battery alarm due to motor error alarm.No frozen screen noted during test and time clock advances properly.Insulin pump received with cracked reservoir tube lip.The test infusion set and reservoir does lock into place.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.
Event or Problem Description
Information received by medtronic indicated that the insulin pump had frequent alarms, had unexplained random no delivery alarms, had rejected new batteries, the clock was slow, rewind took longer and the pieces around the reservoir area had cracked.No harm requiring medical intervention was reported.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAP
• 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: 10480836
• Report Number: 2032227-2020-170757
• Device Sequence Number: 14110105
• Product Code: OYC
• UDI-Device Identifier: 00613994407702
• UDI-Public: (01)00613994407702
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 09/01/2020

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-522LNAP
• Device Catalogue Number: MMT-522LNAP
• Device Lot Number: A000114033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 83