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Model Number MMT-105ELGYNA |
Device Problems
Computer Software Problem (1112); Material Too Rigid or Stiff (1544)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/22/2024 |
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.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.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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Event Description
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It was reported to medtronic minimed that the customer experienced difficult to dial/dose, dose log/report data inaccuracy.The customer reported no adverse event.The event involved product(s) mmt-105elgyna.Troubleshooting was performed for the event.No harm requiring medical intervention was reported.Mmt-105elgyna was requested and customer response was the device will be returned.
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Manufacturer Narrative
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Inpen did not pair with commercial app.However, inpen did transmit to manufacturing app.Received inpen [ 1/4 ] of travel.Performed encoder bond investigation and found that the encoder pattern wheel tabs rotating and traveling off the keyed slots of dose nut guides.Encoder pattern wheel should never rotate.This causes an unexpected travel of the encoder pattern wheel creating resistance to dial and dispensing.Also, plastic shavings contamination builds up found caused by encoder wheel tabs rubbing at the walls of the dose nut.Abrasions only at the top section of the dose nut.Unable to perform baseline/wireless functionality and displacement dose accuracy test.Inpen failed front cap investigation.Inpen front shell does not fit securely onto cartridge holder due to small snap arm being cracked / broken.In conclusion: it was determined from destructive analysis that the difficult to dial/dose was caused by a pattern wheel misalignment due to an encoder base bond failure.This can affect insulin delivery.Therefore, the customer concern of dose dial being difficult to dial/dose was 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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