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 2016-09-02 for CHROMID? STAPH AUREUS 43371 manufactured by Biom?rieux Espa?a.
[53791290]
An investigation into a false negative event while using the chromid? Staph aureus plates was performed. The chromid? Staph aureus failed to grow a qc-strain on multiple attempts. A complaint trend review was performed on this lot. No other similar complaints have been received. Four atcc? Quality control samples (atcc? 2593, atcc? 6538, atcc? 29971, and atcc? 15305) were inoculated onto retain plates from the implicated lot as well as 4 lots from varying expiry dating, similar to implicated plates, at expiry, middle of shelf-life, and freshly manufactured. Additionally, customer returned samples were inoculated with the same atcc? Quality control samples. All plates inoculated grew the organism as expected. Based on the results of the investigation, the complaint could not be confirmed and the product is operating within specifications.
Patient Sequence No: 1, Text Type: N, H10
[53791291]
A customer reported to biomerieux a discrepant result event occurred when using the chromid? Staph aureus plate. The customer reported that a quality control sample failed to grow on the chromid? Staph aureus plate. The customer did repeat the quality control sample twice with the same results of no growth observed. Since the incident involved quality control samples and not patient samples, no adverse impact to the patient or delay in results was experienced. An investigation has been initiated by biomerieux to investigate this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2016-00162 |
| MDR Report Key | 5924147 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-02 |
| Date of Report | 2016-08-08 |
| Date Mfgr Received | 2016-08-08 |
| Date Added to Maude | 2016-09-02 |
| 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 | 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 | 2016-09-02 |
| Returned To Mfg | 2016-08-22 |
| Catalog Number | 43371 |
| Lot Number | 1004942170 |
| Device Expiration Date | 2016-10-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-09-02 |