MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
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Model Number MMT-1715K |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Dyspnea (1816); Fatigue (1849); Hyperglycemia (1905); Tachycardia (2095)
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Event Date 01/18/2020 |
Event Type
Injury
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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.(b)(4).
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Event Description
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The customer reported via phone call that the customer were hospitalized due to high blood glucose on (b)(6)2020.The customer¿s blood glucose level was over 250 mg/dl.At the time of hospitalization.Customer¿s blood glucose level was 568 mg/dl, at the time of incidence.Customer had fatigue, heart rate beating fast and heavy breathing.Customer was treated with intravenous drip for high blood glucose level.Customer was advised to troubleshooting.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Unit passed the functional test, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and the dat test at 0.08730 inches.The insulin flow blocked alarm functions properly during the basic occlusion test, occlusion test and force sensor test.No unexpected insulin flow blocked alarm/no delivery alarm noted during testing.Unit uploaded properly using carelink.Unit had scratched case, faded serial number label, keypad overlay texture damage, pillowing keypad overlay, cracked keypad overlay at the select button, stained keypad overlay and cracked retainer.The test p-cap and reservoir does lock in place in the reservoir 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-0955-2020.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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