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

Model Number	MMT-522LNAH
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2017
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.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
The customer reported via phone call that the insulin pump had a blank display.The customer¿s blood glucose level was 223 mg/dl at the time of the incident.Customer stated that she received a low battery alert, replaced the battery and the pump will not turn on.The customer was assisted with troubleshooting and found that there is a crack on the top of the battery housing.Customer also mentioned that the battery cap is hard to remove.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Pump passed the functional testing, including the operating currents measurement, self test, unexpected restart error test, displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test.Pump was monitored for several days and no blank display anomaly noted.No damage found on lcd isolation tape noted.No unexpected low battery alarm noted.Pump had cracked battery tube threads, broken reservoir tube lip, minor scratched display window and stripped battery cap coin slot (p).A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAH
• 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: 6615305
• Report Number: 2032227-2017-20728
• Device Sequence Number: 16321737
• Product Code: OYC
• UDI-Device Identifier: 00613994597212
• UDI-Public: (01)00613994597212
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2017

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-522LNAH
• Device Catalogue Number: MMT-522LNAH
• Device Lot Number: A000139228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 173