MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-12-30 for CHROMID? STAPH AUREUS 43371 manufactured by Biom?rieux Espa?a.
[63694581]
A customer in (b)(6) notified biom? Rieux 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.
Patient Sequence No: 1, Text Type: D, B5
[73471693]
A customer in (b)(4) notified biom? Rieux 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? 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 33-37? C:? 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? 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00535 |
| MDR Report Key | 6216357 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-30 |
| Date of Report | 2017-03-29 |
| Date Mfgr Received | 2017-03-06 |
| Date Added to Maude | 2016-12-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | ISAAC NEWTON, 6 TRES CANTOS |
| Manufacturer City | MADRID, SPAIN 28760 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 28760 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID? STAPH AUREUS |
| Generic Name | CHROMID? STAPH AUREUS |
| Product Code | JWX |
| Date Received | 2016-12-30 |
| Catalog Number | 43371 |
| Lot Number | 1005299430 |
| Device Expiration Date | 2017-03-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX ESPA?A |
| Manufacturer Address | ISAAC NEWTON, 6 TRES CANTOS MADRID, SPAIN 28760 SP 28760 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-30 |