H.
6 eval method: obtained clinical isolate from customer and tested on products involved i.
E.
Hnid panels and microscan walkaway instrument system.
Reviewed complaint history, performance evals, labeling and literature regarding reported issue.
H.
6.
Results: biotype reported by user was duplicated by microscan technical services lab.
Atypical results suggest and footnotes indicate n.
Gonorrhoeae identification required add'l tests to confirm.
Results from add'l tests should lead to a presumptive identification on n.
Meningitidis.
Results of complaint history review revealed a very low complaint volume for this issue.
An external performance eval was done in 1992 to assess the hnid product and accuracy for n.
Meningitidis identification was 92.
1% (70/76 correct id).
Product labeling review indicated instructions are adequate but could be enhanced to increase visibility to the user.
Literature review revealed the following: technical communication was sent to users in 1993 alerting them to existence of maltose negative n.
Meningitidis strains.
Proficiency testing sample (cap) in 1992 included an organism with this profile.
It was also the subject of two continuing education series (tech sample and cacmle) where emphasis was placed on correlating n.
Gonorrhoeae identification with pt history and confirming with second method where there are medical and/or legal implications.
H.
6.
Conclusion: device performance was within labeling claims.
Biotype obtained would lead to footnotes which direct user to confirm identification for this atypical strain (non-reactive neisseria) with add'l tests provided and to use alternate method if the specimen had legal/and or medical implications.
It also suggests that strains on n.
Meningitidis that are glucose and/or maltose negative have been isolated and add'l testing may be required to confirm identification of these unusual strains.
In this event the user did send the specimen to the state reference lab for confirmation but did not perform add'l tests.
The state reference lab reported the identification as n.
Meningitidis.
The pt recovered with treatment and was released.
3.
Eval summary: users need to use the biotype provided by the test panel in conjunction with all of the info provided in the hnid labeling and dms software to ensure correct identification.
The biotype generated from the hnid test panel with this organism referenced footnoes a, b and d.
This info is provided to the user in the hnid codebook included in each box of panels, in the microbiologics info operator's manual provided with each microscan intrument (and software updates when applicable), in selected dms generate reports and screens and the biotype voice response system.
The footnotes provide add'l info and instruction to assist the user in confirming the identification.
An identification of n.
Gonorrhoeae should be correlated to the pt's clinical history.
If the pt's history does not correlate with the n.
Gonorrhoeae or there are medical or legal implications the result should be confirmed by an alternate method.
Some states require confirmation prior to reporting n.
Gonorrhoeae.
According to the 2000 medical letter the first and second choice antibiotics recommended for infections caused by n.
Meningitidus and n.
Gonorrhoeae are very similar.
Therefore, it is unlikely that the misidentification would alter pt treatment.
Since indentification of n.
Meningitidis would warrant infection control measures and prophylactic treatment of persons who had been in close contact with the pt, there could be an increased public health risk if the n.
Meningitidis indentification was delayed or missed.
Corrective action will include distribution of technical bulletin to all microscan users reminding them of the existence of maltose negative n.
Meningitidis and reinforcing the importance of using footnotes in conjunction with hnid panel test results before finalizing the indentification.
In addition, hnid labeling improvements will be made to increase visibility of this info to the user.
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