MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1711K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-1711K |
Device Problems
Connection Problem (2900); Patient Device Interaction Problem (4001)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Date 11/06/2020 |
Event Type
Injury
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Manufacturer Narrative
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The insulin pump involved in this event is the 640g insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.(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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
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Event Description
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Information received by medtronic indicated that the insulin pump had detached retainer ring and reservoir was not able to lock in place.Customer was involved in an accident and currently in hospital, insulin pump damaged during incident.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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The device did not have a battery installed when received.Device passed the self test, sleep current measurement, active current measurement, rewind test, prime or seating test, basic occlusion test and force sensor test.Unable to perform the displacement test, occlusion test and dat test due to missing retainer.The test p-cap and reservoir will not lock in place in the reservoir compartment due to missing retainer.Device uploaded properly using carelink.Device also had a missing reservoir tube o-ring, minor scratched display window, scratched case, missing serial number label, pillowing keypad overlay and cracked keypad overlay at the select button.
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Manufacturer Narrative
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This report is part of a retrospective review and remediation efforts in response to a warning letter.Updated h9: z-0958-2020.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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