MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1712P 640G 3ML PURPLE MG; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
|
Back to Search Results |
|
Model Number MMT-1712P |
Device Problems
Break (1069); Component Missing (2306)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 03/22/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
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 broken retainer.The insulin pump involved in this event is the paradigm real-time 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.
|
|
Event Description
|
It was reported that the customer's insulin pump was damaged.The customer's blood glucose level was unknown at the time of the incident.The customer reported that the pieces on the insulin pump and o ring were missing.The customer was assisted in troubleshooting and it was reported that the reservoir was able to lock into place when inserted inside the insulin pump.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be returned for analysis.
|
|
Manufacturer Narrative
|
The initial report was submitted with the wrong aware date.The correct date is 19 july 2019.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|