MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KL 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
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Model Number MMT-1715KL |
Device Problems
Break (1069); No Apparent Adverse Event (3189)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
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Event Description
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Medtronic legal received information regarding that insulin pump's retainer ring was missing or broken from the attorney of the family.The information received on november 22, 2021.Attorney reporter alleged that use of medtronic insulin pump caused personal injury to the customer on (b)(6) 2019.No harm requiring medical intervention was reported.The insulin pump will not be returned for analysis.Reporter alleges that the use of one or more medtronic minimed 600 series insulin pumps with a damaged, missing, or broken retainer ring caused the claimant to suffer personal injuries.The allegation did not specify the pump identifier (serial number) and therefore all 600 series insulin pumps in possession of the claimant, including this pump, are considered potentially within the scope of the report pending confirmation of the affected (b)(4).When and if the affected serial number is identified, all related reports will be updated accordingly.
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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-0955-2020.This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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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