Model Number MMT-1712K |
Device Problems
Break (1069); Component Missing (2306); Naturally Worn (2988)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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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.(b)(4).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.
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Event Description
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It was reported that the customer had issues with their insulin pump.It was reported that the pump was broken at the reservoir connection and had missing o-rings.It was reported that the display was worn and damaged.No further information provided.
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Manufacturer Narrative
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The insulin pump was received unable to perform displacement test due to missing the retainer.The insulin pump had pillowing keypad overlay, cracked select button on keypad overlay, scratched casing, minor scratches on the lcd window, damaged keypad overlay texture, faded serial number label and peeling end cap address label.The insulin pump was missing the retainer and the reservoir tube o-ring.
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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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Search Alerts/Recalls
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