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 2016-08-29 for CHROMID? CPS? ELITE 418284 manufactured by Biom?rieux Sa.
[53400301]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[53400302]
A customer in (b)(6) reported the occurrence of no growth for streptococcus agalactiae and enterococcus faecalis in association with the chromid cps elite agar. There was little to no growth after 36 hours of incubation, where growth was expected. The customer stated there is a very small amount of growth like film similar to pseudomonas. When the customer performs a gram stain and sub-cultures to cos media, they obtain enterococcus or streptococcus. There is no indication or report from the hospital or treating physician to biomerieux that the occurrence led to any adverse event related to a patient's state of health. Culture submittal has been requested from the customer by biomerieux for internal investigation. Biomerieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[57602515]
This report was initially submitted following a report from a customer in (b)(6) regarding the occurrence of no growth for streptococcus agalactiae and enterococcus faecalis in association with the chromid? Cps? Elite agar (cpse). There was little to no growth after 36 hours of incubation, where growth was expected. Biom? Rieux investigation was conducted. Strains were not available from the customer; this investigation was conducted with streptococcus agalatiae and enterococcus faecalis strains from the qc lab collection. Evaluation of the manufacturing batch records for the implicated lot of chromid? Cps? Elite agar indicated no non-conformity or observation that could explain the reported issue. The lot conformed with specifications. The investigation performed testing of all strains used as routine quality control in addition to streptococcus agalatiae and enterococcus faecalis strains using retention samples from various cpse batches of varied manufacturing dates. The lot in use at the customer site had expired at the time of investigation. Even so, the investigation tested retains from that lot and a recently manufactured lot with an expiration of (b)(6) 2016. The expected results were obtained for all tests and matched the initial manufacturing qc results. The cpse agar is performing as intended. The package insert for this product indicates: some strains may not give characteristic color on the media, as coloration of strains is influenced by the expression of that individual strain. Therefore, identification of the microorganism isolated must be followed by additional tests whatever the coloration is. Growth depends on the requirements of each individual microorganism. It is therefore possible that certain strains which have specific requirements (substrate, temperature, incubation conditions, etc. ) may not develop on the medium.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00157 |
| MDR Report Key | 5911608 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-29 |
| Date of Report | 2016-08-03 |
| Date Mfgr Received | 2016-08-03 |
| Device Manufacturer Date | 2016-06-09 |
| Date Added to Maude | 2016-08-29 |
| 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 | HAZELWOOD 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 |
| Generic Name | CHROMID? CPS? ELITE |
| Product Code | JXA |
| Date Received | 2016-08-29 |
| Catalog Number | 418284 |
| Lot Number | 1004930970 |
| Device Expiration Date | 2016-10-05 |
| 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 SA |
| Manufacturer Address | 5, RUE DES AQUEDUCS CRAPONNE, FR 69290 FR 69290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-29 |