Model Number MMT-1714K |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Hypoglycemia (1912); Seizures (2063)
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Event Date 05/26/2019 |
Event Type
Injury
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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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The customer reported via phone call that the customer was hospitalized due to hypoglycemia on (b)(6) 2019.
The customer¿s blood glucose level was 1.
3 mmol/ at the time of incident.
The customer was assisted with troubleshooting.
The customer did not mention nay treatments and symptoms related to low blood glucose event.
Customer was using insulin pump system within 48 hours of reported low blood glucose event.
Customer reports they contacted their health care professional regarding the low blood glucose.
Customer stated that the insulin pump was not alleging over delivering.
Customer stated insulin exited at the quick release.
Customer reports basal rates were programmed accurately.
Customer reports bolus wizard was programmed accurately.
Customer was unable to complete carelink upload.
The device will not be returned for analysis.
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Manufacturer Narrative
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The information that provided in date of event with the initial report was incorrect.
The correct information has been included with this report.
Additional information has been received which was not included with the initial report.
The information has been provided with this report.
(b)(4).
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Event Description
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It was reported via phone call the customer had visit to the emergency room due to low blood glucose level and seizure and troubleshooting did not mention about checking quick release, basal or bolus wizard settings.
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Search Alerts/Recalls
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