MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754WWS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-754WWS |
Device Problems
Display or Visual Feedback Problem (1184); Failure of Device to Self-Test (2937)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/26/2023 |
Event Type
malfunction
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Event Description
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Information received by medtronic indicated that the insulin pump had a partial display.Troubleshooting was performed and found partial display and the self test failed.No harm requiring medical intervention was reported.The customer will discontinue the use of the device and the pump will be returned for analysis.
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Manufacturer Narrative
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This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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.Select patient information cannot be provided due to regional privacy regulations.The reported device is not marketed in the united states, but it is a same/similar device to one that is marketed outside the united states.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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Manufacturer Narrative
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Unit received with missing segment/partial display.Unable to perform operating currents, rewind test, self-test, a21 error test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test, displacement test and verify device test failed or download file history due to missing segment/partial display.No moisture damage found on the electronics, motor, battery tube and vibrator assembly noted.Swapping out test boards confirms missing segment/partial display, problem isolated to lcd board.The test reservoir locked in place properly and no anomaly noted.The following were noted during visual inspection: scratched case, stained keypad overlay, cracked battery tube threads, cracked belt clip slot, stained address/serial number label and missing end cap sticker.Unable to verify device test failed and download file history due to missing segment/partial display.Unit received missing segment/partial display; problem isolated to lcd board confirmed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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