Model Number MMT-751LNAS |
Device Problems
False Reading From Device Non-Compliance (1228); Defective Component (2292); Failure to Deliver (2338); Device Displays Incorrect Message (2591)
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Patient Problem
Hyperglycemia (1905)
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Event Date 05/26/2018 |
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.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 they experienced high blood glucose.The high blood glucose was over 503 mg/dl at the time of incident.The other relevant blood glucose was 353 mg/dl.The customer was treated with insulin pump and manual injection for high blood glucose.The customer also stated that the sensor had inaccurate readings that triggered threshold suspend alarm.The customer¿s blood glucose was 503 mg/dl and the sensor glucose was 73 mg/dl.Insulin delivery was suspended due to sensor values.Sensor value that triggered the suspend event was 50 mg/dl to 60 mg/dl.Suspend on low limit in sensor settings was 70 mg/dl.The insulin pump will and sensor will not be returned for analysis.
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Manufacturer Narrative
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Concomitant products were added.
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Search Alerts/Recalls
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