Model Number MMT-7008A |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Material Twisted/Bent (2981)
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Patient Problems
Hyperglycemia (1905); Hypoglycemia (1912)
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Event Date 04/09/2018 |
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 that the sensor had inaccurate readings.The customer¿s blood glucose were 206 mg/dl, 49 mg/dl and the sensor glucose were 73 mg/dl, 98 mg/dl respectively.The customer was informed that their blood glucose and sensor glucose levels were not in acceptable range.Customer removed the sensor and it was slightly bent.Customer declined troubleshooting for blood glucose readings.The sensor will not be returned for analysis.
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Manufacturer Narrative
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The information provided in concomitant reporting section with the initial report was incorrect.The correct information has been included with this report.
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Search Alerts/Recalls
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