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 2018-03-02 for CHROMID? STRB AGAR 43461 manufactured by Biomerieux Sa.
[101697817]
A customer in (b)(6) notified biom? Rieux of media shrinkage that lead to a delayed result greater than 24 hours with chromid? Strb agar (reference 43461). The customer reported that the media shrinkage was observed on some plates after incubation. However, this issue has caused delayed results greater than 24 hours due to repeat testing. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00025 |
| MDR Report Key | 7309693 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-02 |
| Date of Report | 2018-06-04 |
| Date Mfgr Received | 2018-05-07 |
| Device Manufacturer Date | 2017-10-17 |
| Date Added to Maude | 2018-03-02 |
| 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 | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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? STRB AGAR |
| Generic Name | CHROMID? STRB AGAR |
| Product Code | PQZ |
| Date Received | 2018-03-02 |
| Catalog Number | 43461 |
| Lot Number | 1006032880 |
| Device Expiration Date | 2018-02-08 |
| 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 | 2018-03-02 |