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 2018-08-30 for GELOSE CHROMID? CPS ELITE 421151 manufactured by Biomerieux Sa.
[119944379]
A customer in (b)(6) reported inhibited growth for a staphylococcus saprophyticus urine strain, from a patient with an urinary infection, in association with gelose chromid? Cps elite (ref. 421151). The customer reported the staphylococcus saprophyticus had inhibited growth on the cps agar and grew very well in asa (blood agar). The customer stated the s. Saprophyticus strain was identified by a conventional method. The customer stated the initial negative result was reported to their client, but the client disagreed as they reprocessed the sample with a different result. The customer reprocessed the sample, and the result was rectified to quantitation above 100,000 cfu/ml s. Saprophyticus. The doctor was informed about the incorrect and rectified results. The customer reported that the patient was not treated incorrectly as the patient had symptoms in which empirical therapy was started after sample collection. The customer stated there was a delay of two additional days to release the correct result. 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. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00174 |
| MDR Report Key | 7834344 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-30 |
| Date of Report | 2018-12-06 |
| Date Mfgr Received | 2018-11-06 |
| Device Manufacturer Date | 2018-06-26 |
| Date Added to Maude | 2018-08-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318805 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | ESTRADA MAPUA 491 - TAQUARA RIO DE JANEIRO - RJ - 22710-26 |
| Manufacturer Country | BR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GELOSE CHROMID? CPS ELITE |
| Generic Name | GELOSE CHROMID? CPS ELITE |
| Product Code | JXA |
| Date Received | 2018-08-30 |
| Catalog Number | 421151 |
| Lot Number | 1006599960 |
| Device Expiration Date | 2018-10-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | ESTRADA MAPUA 491 - TAQUARA RIO DE JANEIRO - RJ - 22710-26 BR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-30 |