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
Break (1069); Crack (1135); Positioning Problem (3009)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/09/2018 |
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.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 their insulin pump was damaged.The customer¿s blood glucose level was 10.6 mmol/l.The customer states the reservoir ring was cracked and broken in half.Troubleshooting was performed for damage and noticed the reservoir was unable to lock in place.Advised to discontinue use of the pump and revert to a back-up plan.Advised the pump will need to be replaced.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Retainer ring = clear.Customer returned insulin pump for alleged cosmetic damage located at the retainer found on (b)(6) 2018.The insulin pump passed the displacement test and p-cap locks properly into the reservoir compartment; however, partially detached retainer ring was noted during testing.The following were noted during visual inspection: missing reservoir tube o-ring, cracked reservoir tube lip, pillowing keypad overlay, cracked case corner of the belt clip rails near the battery compartment and cracked battery tube threads.Cosmetic damage was confirmed on the retainer.(b)(4).
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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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