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
No Display/Image (1183); Failure to Power Up (1476); Device Dislodged or Dislocated (2923)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/10/2018 |
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.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 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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The customer's parent reported via phone call that the insulin pump had a blank display.The customer¿s blood glucose level was 352 mg/dl at the time of the incident.The parent states the customer replaced the battery but now pump does not turn on.The customer was assisted with troubleshooting and the display did not return.The parent states the clear ring from the reservoir compartment would come lose.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The report has been sent to local office to replace the pump.
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Manufacturer Narrative
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Pump passed the self test, sleep current measurement, active current measurement.Pump powered up properly after battery installation.No blank display noted.Pump received with missing retainer, broken reservoir tube lip, missing reservoir tube o-ring.Unable to perform the displacement test or lock reservoir into place due to missing retainer.Pump also received with cracked case behind the pump near the battery compartment.
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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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