MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1712K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-1712K |
Device Problems
Break (1069); Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198); Device Difficult to Program or Calibrate (1496)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/03/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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.The insulin pump involved in this event is the ngp 640g insulin pump which is not marketed in the united states.However, the device is similar to the ngp insulin pump, which is marketed in the united states.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.
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Event Description
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Information received by medtronic indicated that the customer was stuck in an alert, and even after pressing an ok button, the insulin pump was still stuck on the alert screen and damaged on insulin pump's battery compartment.The insulin pump's buttons not pressed for 3 minutes or more, and was not exposed to fluid or altitude.Customer was able to clear alarm and complete the rewind.No harm requiring medical intervention was reported.Troubleshooting was successfully performed; however, the customer will continue using the device.The product will be returned for analysis.
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Manufacturer Narrative
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Retainer ring black.Case type ngp.Customer returned pump for alleged partial display, keypad unresponsive, pump error 23, and cosmetic damage located at the battery compartment found on 03-dec-2022.Pump was received with unresponsive keypad, and pump booted up properly, partial display was not noted.Unable to perform displacement test and self test due to unresponsive keypad.Test p-cap locked properly into the reservoir compartment.The pump passed the keypad voltage test.Unable to download pump history files and traces using thus software due to unresponsive keypad.Pump was cut open to perform visual inspection and found moisture damage on the electronic assembly (pcba 1 and pcba 2), force sensor, corroded keypad trace, motor, and keypad flex connecting cable.The following were also noted during visual inspection and found: battery cap contact damaged, scratched case, pillowing keypad overlay, stained keypad overlay, corroded battery tube, and corroded battery tube spring.Partial display was not confirmed during testing.Unresponsive keypad was confirmed during testing due to moisture damage on the keypad flex connecting cable and the keypad trace.Unable to verify customer's complaint for pump error 23 due to unresponsive keypad.Cosmetic damage at the battery compartment was not confirmed, however, other cosmetic damage was noted.Moisture damage was confirmed found on moisture damage on the electronic assembly (pcba 1 and pcba 2), force sensor, corroded keypad trace, motor, and keypad flex connecting cable.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.
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