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 2017-03-02 for CHROMID? CPS? ELITE AGAR 418284 manufactured by Biom?rieux S.a..
[68772130]
A customer in (b)(6) reported the occurrence of no growth when testing multiple patients' samples for urine culture while using the chromid? Cps? Elite agar. The customer mentioned that they had proceeded with the subculture of the patients' strains' in macconkey agar and that they could formerly identify the colonies as proteus and escherichia coli using additional tests. No further detail was provided. The customer said that they had observed the same issue with the previous batch of cpse reference 418284. In mitigation of the lack of growth observed by the customer, the device instruction for use - limitation of the method states growth depends on the requirements of each individual microorganism. It is, therefore, possible that certain strains which have specific requirements (substrate, temperature, incubation conditions, etc. ) may not develop on the medium. The customer stated that no biased results were reported to a physician and that the patients concerned had not been harmed as a result of the reported events. There is no indication or report from the hospital or treating physician to biom? Rieux that the occurrence led to any adverse event related to a patient's state of health. There may be a potential for adverse event if the event were to reoccur; therefore, this event is being reported as a malfunction. Culture submittal has been requested from the customer by biom? Rieux for internal investigation. Biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[74515782]
A customer in (b)(4 reported the occurrence of no growth when testing multiple patients' samples for urine culture while using the chromid? Cps? Elite agar. The strains and plates were not available from the customer for evaluation. An investigation was performed. The quality control strains tested were: e. Coli atcc 25922. E. Coli 9909604. Klebsiella pneumoniae atcc 13883. Proteus mirabilis atcc 12453. Enterococcus faecalis atcc 29212. After inoculation of retained samples of the chromid? Cps? Elite agar batch, and incubation for 18-24 hours, the sensitivity of identifying the e. Coli and proteeae strains according to the color and morphology of the colonies, was excellent. The e. Coli strains produced the expected colony appearance by developing a spontaneous red to burgundy color, and producing beta-glucuronidase ( beta-gur) and/ or beta-galactosidase ( beta-gur). The proteus strain produced a spontaneous diffused brown color, and produced deaminase. The klebsiella strain produced the expected colony appearance by developing a spontaneous blue to green color and producing beta-glucosidase ( beta-glu). The enterococcus strain produced the expected colony appearance by developing a spontaneous turqouse color and producing beta-glucosidase ( beta-glu). In summary, the findings were expected and within the acceptance criteria for quality control. A review of quality records confirmed the lot of chromid? Cps? Elite agar conformed to manufacturing specifications and final release criteria. The investigation concluded the customer issue is not related to the performance of the chromid? Cps? Elite agar. The investigation findings are equivalent to the released batch. All strains were recovered at 18-24 hours and the enzymatic reactions were as the ones expected, and did produce a false negative reaction on the batch. The problem could be linked with clinical sample management and/or inoculation. This medium is very sensitive to temperature, although stability data supports thermal shock is related to order preparation and customer distribution, any deviation linked with storage could explain the loose of sensitivity. However, this could not be confirmed without the customer's agar plates. The package insert has the limitation: growth depends on the requirements of each individual microorganism. It is therefore possible that certain strains which have specific requirements (substrate, temperature, incubation conditions, etc. ) may not develop on the medium, although is very strange that 2 do not grow at the same time without the customer strains or agar plates, further investigation is not possible.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2017-00040 |
| MDR Report Key | 6371534 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-02 |
| Date of Report | 2017-04-20 |
| Date Mfgr Received | 2017-03-23 |
| Date Added to Maude | 2017-03-02 |
| 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 | MS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | 5, RUE DES AQUEDUCS CRAPONNE, FR 69290 |
| Manufacturer Country | FR |
| 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 | 2017-03-02 |
| Catalog Number | 418284 |
| Lot Number | 1005333320 |
| Device Expiration Date | 2017-03-27 |
| 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 S.A. |
| Manufacturer Address | 5, RUE DES AQUEDUCS CRAPONNE, FR 69290 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-02 |