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 2016-04-27 for ETEST? CIPROFLOXACIN CI 32 WW F100 508618 manufactured by Biomerieux, Sa.
[43779153]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[43779154]
A customer notified biomerieux of discrepant results using etest ciprofloxacin ci 32 (reference 508618/lots 1003052100 and 1003981160) for a pseudomonas aeruginosa qc sample. An internal biomerieux investigation will be conducted.
Patient Sequence No: 1, Text Type: D, B5
[46712513]
A customer in sweden notified biom? Rieux of a discrepant result associated with etest ciprofloxacin ci 32 involving failed quality control (qc) results for pseudomonas aeruginosa atcc 27853 sample. The qc results obtained by the customer were out of range low. An internal biom? Rieux investigation was performed with results as follows: qc tests were performed with etest ciprofloxacin ci 32 and pseudomonas aeruginosa atcc 27853. The qc tests were performed 3 times with the customers lot. Results- qc results obtained with pseudomonas aeruginosa atcc 27853, were not conform. The customer's issue was reproduced. Qc values obtained with this strain were below the limit values of the range: 0. 25? G/ml. However, no reference batch was tested in parallel. Therefore, a complementary study was performed on atcc 27853 and pseudomonas clinical strains. The pseudomonas aeruginosa atcc 27853 was tested with all the lots of etest ciprofloxacin ci 32 foam and spb (not already expired and available on the market) on mhe and mh bd agar. Results: one-hundred thirty (130) strips have been tested on mhe agar: five (5) non-conformities were observed (mic: 0. 125? G/ml) - 3. 8% of non-conformed results. One-hundred thirty (130) have been tested on mhbd agar - results were conformed for all lots. On 260 strips tested, with any agar used, only five (5) non-conformities (mic: 0. 125? G/ml) have been detected with pseudomonas aeruginosa atcc 27853, meaning 1. 9% non-conformity. In conclusion, the rate of the non-conformity on the lots in the market is 1. 9% (3. 8% when etest ciprofloxacin ci 32 is used on mhe agar, 0% when using mhbd agar); therefore, within the acceptance criteria of the fda and iso standard (<=5%). -an investigation was performed with a complementary kit (44 strains) of pseudomonas clinical strains with etest ciprofloxacin ci 32 on mhe and mh bd agar. The strains tested were representative of the concentration range of etest ciprofloxacin ci 32 and of the critical concentrations of clsi and eucast standards. Twenty- one (21) of the 44 strains had a mic value between (0. 5-4mg/l) corresponding to the critical concentrations of the eucast and clsi standards. This specific selection of the strains and the precision of the antibiotic susceptibility testing method that is currently accepted (+/- 1 dilution), could lead to an increase of the minor errors (threshold effect). Then, in parallel, the qc strain p. Aeruginosa atcc 27853 was also tested. Reference methods used: agar dilution (ad) method - reference method used at the moment of the registration of the etest ciprofloxacin ci 32 product. Broth micro-dilution (bmd) method - reference method recognized by the clsi and eucast used as a complementary method to complete the characterization level of the strains to evaluate the clinical impact of potential discrepancies with the agar dilution (ad) method. The results of the different studies state the following: the results obtained during the different studies on pseudomonas aeruginosa strains state that etest ciprofloxacin ci 32 could lead to a potential specifications output for the qc p. Aeruginosa atcc 27853 strain (mic: 0. 125? G/ml lowest value for an expected range between mic: 0. 25-1? G/ml) for less than 5% of the strips tested (accepted rate for the fda and iso) but without any impact on product performance; therefore, with no patient risk based on this study. In conclusion of the review of this issue, no additional actions deemed necessary in the field.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00073 |
| MDR Report Key | 5610906 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-04-27 |
| Date of Report | 2016-04-06 |
| Date Mfgr Received | 2016-04-06 |
| Date Added to Maude | 2016-04-27 |
| 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 | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| Manufacturer G1 | BIOMERIEUX, SA |
| Manufacturer Street | 3 ROUTE DE PORT MICHAUD |
| Manufacturer City | LA BALME LES GROTTES ISERE, 38390 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 38390 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETEST? CIPROFLOXACIN CI 32 WW F100 |
| Generic Name | ETEST? CIPROFLOXACIN CI 32 WW F100 |
| Product Code | JWY |
| Date Received | 2016-04-27 |
| Catalog Number | 508618 |
| 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 | 3 ROUTE DE PORT MICHAUD LA BALME LES GROTTES ISERE, 38390 FR 38390 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-27 |