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 2017-06-22 for CHROMID? CPS ELITE AGAR 416172 manufactured by Biom?rieux Sa.
[78267796]
A biom? Rieux internal investigation was perfromed. Innoculation of some additional species of citrobacter spp and hafnia alvei strains coming from atcc collection were performed, considering that some atypical strains such as citrobacter and h. Alvei could give pink coloration. These include: citrobacter freundii atcc 8090, citrobacter freundii atcc 8144101, hafnia alvei atcc 29926, hafnia alvei atcc 8208040. After inoculation, the sensitivity of identifying e. Coli according to the color and morphology of the colonies was excellent for the batch complaint after incubation for 18-24 hours , thereby, e. Coli strains produced the expected colony appearance, developing as spontaneous red to burgundy coloration, producing beta-glucuronidase (beta-gur) and/ or beta-galactosidase (beta-gur). Moreover, kesc strains, including both additional strains of citrobacter spp, produced the expected colony appearance developing as spontaneous blue to green coloration producing beta-glucosidase ( beta-glu). Both challenge strains for h. Alvei that were tested appeared as colorless colonies , not able produce acid from lactose or d-sorbitol and failure to elaborate the enzyme beta-d-glucuronidase. Based on these results, the problem was not confirmed during the investigation with the retention samples and the internal strain collection, nevertheless, it is common for most of h. Alvei strains to develop as colorless colonies; therefore, the different color among the customer strain and both h. Alvei internal strains (atcc 8208040 and atcc 29926) could be explained because this particular strain was isolated from a urinary sample and showed atypical enzymatic pathways expressing bet]-gur activity, confirming that problem is not batch or product related. Seems to be related with the particular clinical strain. Nevertheless, the specificity issue with h. Alvei is already known. It has been detected during the cps elite clinical study. So it is part of the specificity of the medium for some particular strains. This is the reason why it is included in limitations in the product insert (specificity of coloration for e. Coli of 97%).
Patient Sequence No: 1, Text Type: N, H10
[78267797]
A customer from (b)(6) reported to biomerieux discrepant results when testing a patient urine sample with chromid? Cps elite agar (cpse) ref 416172, lot 1005585060. The customer tested the urine sample on cpse and observed a colony with color, characteristic of escherichia coli. The customer then performed susceptibility testing with vitek? 2 and found discrepant resistance. The sample was then tested with the vitek? 2 gn card and was identified as hafnia alvei at 98-99%. The customer reported no incorrect result was reported to the physician; however there was a delay greater than 24 hours due to the additional tests performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00145 |
| MDR Report Key | 6661146 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-22 |
| Date of Report | 2017-06-22 |
| Date Mfgr Received | 2017-05-23 |
| Device Manufacturer Date | 2017-03-22 |
| Date Added to Maude | 2017-06-22 |
| 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 | MRS. 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 | 5, RUE DES AQUEDUCS |
| Manufacturer City | CRAPONNE, FR 69290 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69290 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID? CPS ELITE AGAR |
| Generic Name | CHROMID? CPS ELITE AGAR |
| Product Code | JXA |
| Date Received | 2017-06-22 |
| Catalog Number | 416172 |
| Lot Number | 1005585060 |
| ID Number | 03573026443900 |
| Device Expiration Date | 2017-07-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX SA |
| Manufacturer Address | 5, RUE DES AQUEDUCS CRAPONNE, FR 69290 FR 69290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-22 |