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 2018-05-01 for VIDAS? C. DIFFICILE GDH 30125 manufactured by Biomerieux Sa.
[107754924]
A customer from (b)(6) notified biom? Rieux of calibration problems with vidas? Gdh (ref 30125). The customer was performing calibration testing with a new lot (1006161620 / 190127-0) on (b)(6) 2018 and obtained invalid calibration results. The customer notified biom? Rieux on (b)(4) 2018 of the issue, and by the end of the day, the calibration was valid. There were patient samples waiting more than 24 hours to be tested. There is no indication from the laboratory that there was any adverse event related to any patient's state of health due to this issue. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00062 |
| MDR Report Key | 7477463 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-01 |
| Date of Report | 2018-07-11 |
| Date Mfgr Received | 2018-06-12 |
| Device Manufacturer Date | 2017-12-14 |
| Date Added to Maude | 2018-05-01 |
| 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 | MRS. CANDACE MARTIN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | 376, CHEMIN DE L'ORME |
| Manufacturer City | MARCY L'ETOILE, 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS? C. DIFFICILE GDH |
| Generic Name | VIDAS? GDH |
| Product Code | MCB |
| Date Received | 2018-05-01 |
| Catalog Number | 30125 |
| Lot Number | 1006161620 |
| Device Expiration Date | 2014-01-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | 376, CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-01 |