Catalog Number DF105A |
Device Problems
Nonstandard Device (1420); High Test Results (2457)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/15/2014 |
Event Type
malfunction
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Event Description
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Biased high hb1c results were obtained on (b)(4) survey samples.It is unknown if patient treatment was altered or prescribed on the basis of the biased high hb1c results.There was no report of adverse health consequences as a result of the biased high hb1c results.
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Manufacturer Narrative
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Siemens healthcare diagnostics has confirmed that the dimension® hb1c flex® reagent cartridge lots ga4266, ba4273, ba4280, ba4287, ga4301, ga4315, gc4322, ga4343, ga4350, ga4357, ga5013, and ga5020 exhibit a positive bias averaging 0.4% hemoglobin a1c units and occasionally up to 1.0% hba1c units for patient samples when compared to the national glycohemoglobin standardization program (ngsp).Qc samples may exhibit a similar bias.This bias resulted in complaints for (b)(4) failures.In the urgent medical device recall letter dated september 2014, # (b)(4) issued to customers who were shipped the impacted lots, siemens directed customers to discontinue use and to discard the impacted lots.Siemens stated it would replace any unused inventory of the affected lots at no charge with a non-affected lot.
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Manufacturer Narrative
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Original mdr was submitted 09/24/2014.As a result of investigations, siemens has confirmed that the dimension® hba1c flex® reagent cartridge lots ga4266, ba4273, ba4280, ba4287, ga4301, ga4315, gc4322, ga4343, ga4350, ga4357, ga5013, and ga5020 exhibit a positive bias averaging 0.4% hemoglobin a1c units and occasionally up to 1.0% hba1c units for patient samples when compared to the national glycohemoglobin standardization program (ngsp).Qc samples may exhibit a similar bias.This bias resulted in complaints for college of american pathologists (cap) survey failures.In the urgent medical device recall letter dated september 2014, #14-60 issued to customers who were shipped the impacted lots, siemens directed customers to discontinue use and to discard the impacted lots.Siemens stated it would replace any unused inventory of the affected lots at no charge with a non-affected lot.
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Search Alerts/Recalls
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