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 2018-02-23 for CHROMID? C. DIFFICILE AGAR 43871 manufactured by Biomerieux Spain.
[101140007]
A veterinary customer from (b)(6) reported no growth on chromid? C. Difficile (lot 1006045090) while conducting an experiment. The customer stated the experiment was repeated using the customer's media (bhiss with added c. Diff supplement) and the chromid plates. Results were obtained with the customer's media but not with the chromid. The samples being tested were fecal specimens from animals that were infected with the c. Difficile 630 strain. The customer reported that samples with the c. Difficile 630 strain always grew well on previous lots of chromid so a reference strain was not used. A biom? Rieux internal investigation will be initiated. Although this event involved animal testing, the product chromid c. Difficile , can be used in a clinical setting and the situation of no growth can recur while testing a patient isolate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00020 |
| MDR Report Key | 7291954 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-23 |
| Date of Report | 2018-04-19 |
| Date Mfgr Received | 2018-03-26 |
| Device Manufacturer Date | 2017-10-23 |
| Date Added to Maude | 2018-02-23 |
| 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 | BIOMERIEUX SPAIN |
| Manufacturer Street | ISAAC NEWTON, 6 |
| Manufacturer City | TRES CANTOS, MADRID 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? C. DIFFICILE AGAR |
| Generic Name | CHROMID? C. DIFFICILE AGAR |
| Product Code | JSI |
| Date Received | 2018-02-23 |
| Catalog Number | 43871 |
| Lot Number | 1006045090 |
| Device Expiration Date | 2018-02-05 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SPAIN |
| Manufacturer Address | ISAAC NEWTON, 6 TRES CANTOS, MADRID 28760 SP 28760 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-23 |