MAUDE Adverse Event Report: BIOMÉRIEUX ESPAÑA CHROMID® STAPH AUREUS

Catalog Number 43371

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of discrepant results associated with the chromid® staphylococcus aureus plate involving a quality control sample.The customer reported no growth on the plates.Quality control was performed on two (2) plates with atcc strains 25923 and 29213.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(4) notified biomérieux of discrepant results associated with the chromid® staphylococcus aureus plate involving a quality control sample.The customer reported no growth on the plates.Quality control was performed on two (2) plates with atcc® strains 25923 and 29213.An investigation was conducted.A review of manufacturing and quality documentation (batch record, raw data, dhr, quality control) confirmed the product conformed to all specifications.The growth of staphylococcus aureus atcc 25923 was ideal.It is noted that staphylococcus aureus atcc 29213 was not tested in the initial control; therefore, as part of this investigation, atcc 29213 was tested on the present batch number.The investigation included a comparison of chromid® staphylococcus aureus batches with qc routine positive strains and both customer strains, following the qc standard procedure.Likewise, the retention sample was tested in parallel with other batches manufactured at different times, to determine if the customer result is reproduced in another batch.The chromid® staphylococcus aureus batches tested are as follows: · customer batch retention sample kept at 2-8 º c (1005299430 expired date 07/03/2017).· fresh chromid® staphylococcus aureus agar (100533210 expired date 21/03/2017).· batch at t middle (1005262000 expired date 15/02/2017).· batch at t expired date (1005144410 expired date: 02/01/2017).· columbia blood agar used as control to make sure that the recovery of all target strain is intended.The qc strains tested to prove the fertility properties of the media: · staphylococcus aureus atcc 25923 · staphylococcus aureus atcc 6538 · staphylococcus aureus atcc 29213.Results after 18-24 hours at 33-37ºc: · for staphylococcus aureus atcc 29213 and staphylococcus aureus atcc 6538, the performance was perfect, without differences among all tested batches.The numeration, size and sensitivity of identifying staphylococcus aureus according to the color and morphology of the colonies, was excellent whatever the batch tested.· for staphylococcus aureus atcc 25923, performance is equivalent regarding growth, however in "older batches" a typical green color is observed at 48 hours instead of 24 hours (this is already referenced in packet package insert for this strain).· performance testing was conducted with the customer's retention samples and plates, in-house atcc staphylococcus aureus strains (25923 and 29213), and atcc strains used by the customer which showed an absence of growth.Results with chromid® staphylococcus aureus retention samples: · the growth of staphylococcus aureus atcc 25923 and staphylococcus aureus atcc 29213 (both in-house and customer samples) are within specifications.· the lack of growth reported by the customer was not reproduced.· regarding coloration, it was observed that staphylococcus aureus atcc 29213 develops the typical green color after 24 hours, while the staphylococcus aureus atcc 25923 needs 48 hours of incubation to develop color.The package insert contains this information.In this case, the particular strain is negative, so incubation time should be extended up to 48 hours.Results with chromid® staphylococcus aureus from customer: · all of the staphylococcus aureus atcc 29213 microbiological parameters were within the acceptance criteria.· the growth density observed in the retention samples (from the same batch) is better than the growth on the customer plates.· regarding color, the enzymatic reaction was as expected.· the density of growth for both staphylococcus aureus atcc 25923 were worse than shown on retention samples.However , as explained before the results in our plates, upon 24 hours longer, if we compared the intensity of coloration for both atcc strains tested between our plates with those provided by the customer , the enzymatic activity was quite similar among the plates; therefore, the difference exhibited at 24 hours was not present.· lack of growth was not observed in the retained plates and the customer plates, where the growth was lower but within specifications.The root cause could be linked to product preservation.Retained plates were stored at 2-8 º c since the manufacturing date while the customer plates have suffered thermal shock.The most likely root cause could be the high sensitivity of this media to light exposure or transport conditions.This medium is very sensitive to temperature, although stability data supports thermal shock as related to order preparation and customer distribution.Any deviation linked with storage could explain the loss of selectivity and/or sensitivity, as we did not confirm the same problem in our retention samples.The package insert states the media must not be exposed to light other than during the inoculation and reading step, so this media is not compatible with 8 hours light exposure.This specific condition is tested during the stability procedure.This fact could explain the failure observed by the customer.

• Brand Name: CHROMID® STAPH AUREUS
• Type of Device: CHROMID® STAPH AUREUS
• Manufacturer (Section D): BIOMÉRIEUX ESPAÑA; isaac newton, 6; tres cantos; madrid, spain 28760 ; SP 28760
• Manufacturer (Section G): BIOMÉRIEUX ESPAÑA; isaac newton, 6; tres cantos; madrid, spain 28760 ; SP 28760
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6216357
• MDR Text Key: 63694581
• Report Number: 3002769706-2016-00535
• Device Sequence Number: 1
• Product Code: JWX
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2017
• Device Catalogue Number: 43371
• Device Lot Number: 1005299430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1