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 2018-06-18 for CHROMID? STREPTO B AGAR 43461 manufactured by Biomerieux Sa.
[112285960]
A customer in ukraine contacted biom? Rieux to report shrinkage of the agar following incubation in association with the chromid? Strepto b kit. The customer indicated a delay in reporting of >24 hours due to the need for retest of the specimen. The duration of incubation and the type of incubation were not provided by the customer. It is also noted the agar lot in use was within one day of expiration. There is no indication or report from the laboratory or physician to biom? Rieux that the delay in reporting 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 | 3002769706-2018-00079 |
| MDR Report Key | 7611466 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-18 |
| Date of Report | 2018-09-27 |
| Date Mfgr Received | 2018-08-31 |
| Device Manufacturer Date | 2018-01-30 |
| Date Added to Maude | 2018-06-18 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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? STREPTO B AGAR |
| Generic Name | CHROMID? STREPTO B AGAR |
| Product Code | PQZ |
| Date Received | 2018-06-18 |
| Catalog Number | 43461 |
| Lot Number | 1006257280 |
| Device Expiration Date | 2018-05-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-06-18 |