Model Number MMT-1715K |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)
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Patient Problems
Hyperglycemia (1905); Skin Irritation (2076); Discomfort (2330)
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Event Date 02/20/2018 |
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 the high blood glucose level and the sensor had inaccurate readings that triggered threshold suspend alarm.The high blood glucose level of the customer was 450 mg/dl.The customer's blood glucose value at which the insulin pump suspend was 189 mg/dl and sensor glucose was 237 mg/dl at the time of the incident.The customer's other blood glucose value was 300 mg/dl and 185 mg/dl.The customer also stated that the insulin pump had a power loss alarm but it was resolved.The customer was assisted with the troubleshooting.The device will not be returned for the analysis.
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Search Alerts/Recalls
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