MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM INSULIN INFUSION PUMP MMT-511NAS; PUMP, INFUSION, INSULIN

Model Number MMT-511NAS

Device Problems Device Difficult to Program or Calibrate (1496); Visual Prompts will not Clear (2281)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2007

Event Type  malfunction  

Event Description

The complaint was previously reviewed in easytrak and was converted into smart solve on (b)(6) 2017.Upon conversion, the complaint record was pushed into reassessment status for review.It was confirmed there was no relevant information to change the reportability decision.

Manufacturer Narrative

No frozen screen noted.Unit passed displacement test and self-test.All buttons were tested while navigating the menus, and they all worked properly.No unlocked j2/lcd keypad connector, button error alarm or other keypad anomalies were noted during testing noted.Pump history download using thds was successful.However, no data available in the history file on event date (b)(6) 2007.Pump was cut and open found no moisture/damage on the electronics, battery connector, battery tube, motor, vibrator, keypad flex tail, keypad trace noted during visual inspection.Unit had scratched case, cracked battery tube threads, cracked reservoir tube lip, scratched reservoir tube window, stained address/serial number label and missing end cap sticker.The test reservoir locked in place properly and no anomaly noted.In conclusion, insulin pump passed all require testing.Frozen screen, back light anomaly, keypad/ button unresponsive were not confirmed.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: PARADIGM INSULIN INFUSION PUMP MMT-511NAS
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer Contact: tricha miles ; 18000 devonshire st.; northridge, CA 91325 ; 7635140379
• MDR Report Key: 16020550
• MDR Text Key: 308128258
• Report Number: 2032227-2022-383373
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-511NAS
• Device Catalogue Number: MMT-511NAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Date Manufacturer Received: 01/20/2007
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Sex: Male
• Patient Weight: 73 KG