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 2018-06-20 for CHROMID? P. AERUGINOSA AGAR 43462 manufactured by Biomerieux Sa.
[112445266]
A customer in the (b)(6) contacted biom? Rieux to report no growth for a neqas specimen (p. Aeruginosa 10) in association with the chromid? Pseudomonas aeruginosa agar plate. The same strain grew of cpse plates. The customer stated the inoculated plates were incubated for 48 hours (read at 24 hours, then re-incubated for a further 24 hours). The customer does not know the lot number of the plates. In addition, the neqas strain was not retained by the customer; therefore no investigation submittal is possible. The customer indicated "this neqas strain was not scored as 23% of labs reported a false negative result; this particular strain had unusual growth requirements". The customer reviewed the package insert for the chromid pseudomonas aeruginosa agar, and it states "growth depends on the requirements of each individual micro-organism. It is therefore possible that certain strains of pseudomonas aeruginosa which have specific requirements (substrate, temperature, incubation atmosphere) may not develop or may not produce typical colonies. " there is no indication or report from the laboratory to biom? Rieux that the false negative result led to any adverse event related to any patient's state of health. There was no patient directly associated with the neqas specimen. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00085 |
| MDR Report Key | 7618707 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-20 |
| Date of Report | 2018-09-18 |
| Date Mfgr Received | 2018-08-23 |
| Device Manufacturer Date | 2018-01-30 |
| Date Added to Maude | 2018-06-20 |
| 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. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | 5 RUE DES AQUEDUCS 69290 CRAPONNE |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID? P. AERUGINOSA AGAR |
| Generic Name | CHROMID? P. AERUGINOSA AGAR |
| Product Code | JSI |
| Date Received | 2018-06-20 |
| Catalog Number | 43462 |
| 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 | 5 RUE DES AQUEDUCS 69290 CRAPONNE FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-20 |