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Model Number UNK_MINIMEDPUMP |
Device Problem
Break (1069)
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Patient Problems
Abdominal Pain (1685); Hyperglycemia (1905); Hypoglycemia (1912); Nausea (1970); Vomiting (2144)
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Event Date 02/14/2018 |
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.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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Event Description
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Medtronic legal received information indicated that in or around 2019 and 2020, the patient's insulin pump malfunctioned due to the retainer ring defect and failed to deliver the appropriate amount of insulin, causing the patient to suffer from diabetic ketoacidosis, vomiting, low blood pressure, and memory impairment.As a result, the patient had been hospitalized on multiple occasions.Customer suffered from diabetic ketoacidosis with blood glucose level up to 677 mg/dl.Customer reported that they had a symptoms like nausea ,abdominal pain, vomiting, fatigue and throat pain.Troubleshooting was performed and found that the customer was hospitalized for less than 1 day on the incident date and the blood glucose value at the time of the incident was unknown.No further patient complications were reported.The insulin pump remains in use and 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 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 serial number(s).When and if the affected serial number is identified, all related reports will be updated accordingly.
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Search Alerts/Recalls
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