MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-08 for SAFRANIN A 29520 manufactured by Biom?rieux Sa.
[92870720]
A customer from (b)(6) reported to biom? Rieux a performance problem with safranin a (reference 29520), a decolorize and counter stain, when performing gram staining with streptococcus strains, in association with the previ? Color gram. The customer reported that they were getting red stains instead of blue. The strains impacted were streptococcus equi atcc, streptococcus pyogenes in broth with an incubation of 4 hours, escherichia coli and staphyloccocus aureus from broth with an incubation of 24 hours; clinical samples were from plates of blood agar and from bact/alert? Culture bottles. The customer stated there was no incorrect result reported, but it took more than 24 hours to cultivate the strains, complete retesting with vitek? And report the results. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. The customer submitted pictures of the affected slides to biom? Rieux and the slides were determined to be over decolorized. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00356 |
| MDR Report Key | 7011404 |
| Date Received | 2017-11-08 |
| Date of Report | 2018-03-20 |
| Date Mfgr Received | 2018-02-23 |
| Device Manufacturer Date | 2017-04-18 |
| Date Added to Maude | 2017-11-08 |
| 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 | 0 |
| Brand Name | SAFRANIN A |
| Generic Name | SAFRANIN A |
| Product Code | KPA |
| Date Received | 2017-11-08 |
| Catalog Number | 29520 |
| Lot Number | G16717 |
| ID Number | 03573026219796 |
| Device Expiration Date | 2018-10-18 |
| 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 | 2017-11-08 |