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 01/05/2018 |
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.The customer¿s blood glucose was 90 mg/dl and the sensor glucose was 40 mg/dl at the time of the incident.Customer stated that, she was in the 40's mg/dl and currently she is in 90's mg/dl and sensor glucose was 42 mg/dl and really it was 84 mg/dl.Troubleshooting was done and customer stated that their blood glucose and sensor glucose levels were not in acceptable range.The sensor will not be 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 failed per specifications due to high readings.See attached file for details.
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Search Alerts/Recalls
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