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 2018-05-25 for VIDAS? GDH 30125 manufactured by Biomerieux Sa.
[109772016]
A customer in (b)(6) notified biom? Rieux of a false positive result associated with vidas? Gdh (reference (b)(4)). The customer reported while performing a correlation study between two (2) vidas? 3 analyzers for vidas? Gdh the discrepancy was observed. The results were as follows: sample 1: stool volume was not doubled; the liquid stool sample had clear separation and perfect supernatant. 1st test on vidas? (b)(4) was obtained positive at 0. 15. 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? 3 (b)(4) was obtained negative at 0. 00. 2nd test on vidas? 3 (b)(4) was obtained negative at 0. 05. 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 | 3002769706-2018-00070 |
| MDR Report Key | 7544663 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-25 |
| Date of Report | 2018-07-11 |
| Date Mfgr Received | 2018-06-12 |
| Device Manufacturer Date | 2017-12-14 |
| Date Added to Maude | 2018-05-25 |
| 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. TIFFANY HALL |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| 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? GDH |
| Generic Name | VIDAS? GDH |
| Product Code | MCB |
| Date Received | 2018-05-25 |
| 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 | 2018-05-25 |