MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722LNAB
Medical Device Problem Code	Priming Problem (4040)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pump alarmed motor error during rewind due to motor encoder signal out of phase.Unable to perform the displacement test, rewind, basic occlusion test, occlusion test, prime test and excessive no delivery test or verify compromised force sensor alarm and possible temporary vent blockage due to motor error alarms.
Event or Problem Description
The customer¿s mother reported via phone call that the insulin pump had priming and the insulin started came out fast.The customer¿s blood glucose level was 70 mg/dl.Customer stated that insulin continued to drip after motor stops during the manual prime process and customer was not wearing the insulin pump during priming.Customer stated that the drive support cap was normal.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAB
• 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: 9338149
• Report Number: 2032227-2019-119173
• Device Sequence Number: 16606702
• Product Code: OYC
• UDI-Device Identifier: 00613994409522
• UDI-Public: (01)00613994409522
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2019

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-722LNAB
• Device Catalogue Number: MMT-722LNAB
• Device Lot Number: A000114649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 20