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Catalog Number 412490
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer in (b)(6) reported a discrepant result (out-of-range-low) for candida albicans, atcc® 90028, associated with etest® voriconazole vo 32 ww s30. The customer reported obtaining an unusual shape result, and the ellipse meets the strip under the lower mic. There are three (3) patients involved in this event with three (3) different sample types; pus, trachea aspiration and catheter. The customer reported the iqc result is not good; the expected range is 0. 004 - 0. 016 and a mic result obtain was lower than 0. 002. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. There may be a potential for adverse event if the event were to reoccur while testing a patient isolate; therefore this event is being reported as a malfunction. Culture submittal was requested by biomérieux for internal investigation. Biomérieux investigation will be initiated.
Manufacturer Narrative
Biomérieux conducted an internal investigation: biomérieux performed an investigation on customer strips of lot 1004803990 and the retained samples from lot 1004803990 and lot 1005016560 mentioned by customer in parallel with another batch as a reference. We did not reproduce the issue observed by the customer on atcc strain 90028. The conformity of batches 1004803990 and 1005016560 mentioned by customer was be confirmed with two (2) others qc stains whose candida parapsilosis atcc 22019 and candida krusei atcc 6258. On three (3) clinical strains, we reproduced the customers results with mic very low or ellipse which ends below the strip (less than 0. 002) randomly. The strains were susceptible. We confirmed the variability of results obtained by the customer. But the result is considered as acceptable. These results are linked to normal variability intra or inter-batches for antifungals. Indeed, this variability is accepted within two (2) doubling dilutions ((b)(4)) unlike antibiotics. However, these strains have mic very low at the limit of etest® strip mic. These strains are very susceptible. In this case the real mic do not have a clinical interest. It's the same thing with high level of mic. The variability increase at the limit of the strips (close to 0. 002 or close to 32mg/l).
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Manufacturer (Section D)
3 route de port michaud
la balme les grottes isere, 38390
FR 38390
Manufacturer (Section G)
3 route de port michaud
la balme les grottes isere, 38390
FR 38390
Manufacturer Contact
ellen weltmer
595 anglum road
st. louis, MO 63042
MDR Report Key6230904
MDR Text Key64132872
Report Number3002769706-2017-00003
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2021
Device Catalogue Number412490
Device Lot Number1004803990
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2016
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage