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

Model Number	MMT-522LNAL
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pump had unresponsive buttons at esc and act due to unlocked j2/liquid crystal display keypad connector during visual inspection.Unable to perform operating currents, self test, unexpected restart alarm error test, rewind test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and displacement test or verify operating currents and motor position encoder error alarm due to unresponsive button.No button error alarm during testing.However, corrosion was found at the keypad traces.The motor was tested outside of the device and passed.
Event or Problem Description
The customer reported via phone call that the insulin pump had motor error alarm.The blood glucose level was 160 mg/dl.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAL
• 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: 8101369
• Report Number: 2032227-2018-66502
• Device Sequence Number: 11099204
• Product Code: OYC
• UDI-Device Identifier: 00613994407719
• UDI-Public: (01)00613994407719
• Combination Product (Y/N): N
• 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): 11/26/2018

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-522LNAL
• Device Catalogue Number: MMT-522LNAL
• Device Lot Number: A000113848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2018
• Initial Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 78