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 2016-07-28 for CHROMID? CPS ELITE AGAR 416172 manufactured by Biom?rieux Sa.
[50663291]
An investigation into a false negative event while using the chromid cps elite agar was performed. The customer did not return the patient samples; therefore, no testing could be performed to confirm the customer's result. Fourteen (14) quality control strains were tested on retain samples from the lot in question as well as another lot. All samples were found to be within specification. A review of the batch production record revealed no related abnormalities. Additionally, a complaint review was performed and this lot does not show an adverse quality trend. 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
[50663292]
A customer notified biomerieux that they had a discrepant result when using the chromidcps elite agar. Four (4) patient samples were run using the chromid cps elite test kit. The patient urine specimens were inoculated directly onto the plate and incubated for 24 hours. In compliance with the package insert, the customer read the plates after 24 hours and found no growth present. The customer incubated the plates for another 24 hours and upon reading the results discovered pink colonies on three (3) plates and blue-green colonies on one (1) plate. When specifically asked, the customer indicated there was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2016-00135 |
| MDR Report Key | 5830129 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-07-28 |
| Date of Report | 2016-06-14 |
| Date Mfgr Received | 2016-06-14 |
| Date Added to Maude | 2016-07-28 |
| 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 AGAR |
| Generic Name | CHROMID? CPS ELITE AGAR |
| Product Code | JXA |
| Date Received | 2016-07-28 |
| Catalog Number | 416172 |
| Lot Number | 1004811180 |
| Device Expiration Date | 2016-08-16 |
| 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 | 2016-07-28 |