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Model Number 700100 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/03/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Customer returned two bottles of specified strips.Bottle 1 was returned with 46 strips; six of these strips were tested, and failed testing reading lo on all three blood levels confirming the complaint.Bottle 2 was returned with 50 strips and passed testing with no failures detected.Two bottles of retain strips were tested as well.Bottle 1 of retains failed testing reading lo on the 150mg/dl and 300mg/dl blood levels.Bottle 2 of retains passed testing with no failures detected.Desiccant testing was performed on failed strip bottles and passed testing indicating moisture intrusion is not the cause of the observed strip failure, indicating that user error is most likely not a factor in the confirmed failure.Complaint products will be forwarded to the manufacturer for further investigation.
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Event Description
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Customer reported issues of low blood readings.Complaint was reviewed for investigation and reportability on (b)(6) 2022.Complaint was marked for investigation and determined not reportable per arkray's per internal procedures.On (b)(6) 2022, returned strips failed testing by generating low results out of specification.The strips gave low readings, making this complaint reportable to the manufacturer as a malfunction.(b)(6) 2022 marks the aware date for mdr filing.
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Search Alerts/Recalls
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