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 2018-07-10 for VIDAS? C. DIFFICILE GDH 30125 manufactured by Biomerieux Sa.
[113910850]
A customer in (b)(6) reported to biom? Rieux that they obtained a false positive result when using the product vidas? Gdh (ref. 30125), lot 1006161620. The customer performed a correlation study between two vidas 3 analyzers (vidas (b)(4) and vidas (b)(4)) for vidas gdh. The results were obtained as follows: sample 1: stool volume not doubled: 1st test on vidas (b)(4) was obtained positive at 0. 25, 2nd test on vidas (b)(4) was obtained negative at 0. 00. Sample 2: doubled stool volume and volume of r1: 1st test on vidas (b)(4) was obtained negative at 0. 00 (non-standard c1 control), 2nd test on vidas (b)(4) was obtained negative at 0. 00 (non-standard c1 control). There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00104 |
| MDR Report Key | 7674193 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-10 |
| Date of Report | 2019-01-08 |
| Date Mfgr Received | 2018-12-13 |
| Device Manufacturer Date | 2017-12-14 |
| Date Added to Maude | 2018-07-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 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 | 2018-07-10 |
| Catalog Number | 30125 |
| Lot Number | 1006161620 |
| Device Expiration Date | 2019-01-27 |
| 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 | 2018-07-10 |