Model Number MMT-7008A |
Device Problems
False Reading From Device Non-Compliance (1228); Device Displays Incorrect Message (2591)
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Patient Problem
Hyperglycemia (1905)
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Event Date 01/09/2018 |
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.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.
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Event Description
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The customer reported via phone call the sensor had inaccurate readings that triggered threshold suspend alarm and high blood glucose.The patient¿s blood glucose was 300 mg/dl and the sensor glucose was 68 mg/dl and it suspended overnight.The product is returned for analysis.
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Manufacturer Narrative
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Inspected one opened and used sensor and performed continuity resistance test.Sensor passed per specification.Also, performed bicarbonate buffer test.Sensor passed per specifications with accurate readings.See attached file for details.
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Search Alerts/Recalls
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