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 2018-04-06 for VIDAS? RUB IGG II 30221 manufactured by Biomerieux Sa.
[105261672]
A customer in (b)(6) notified biom? Rieux of a false negative result associated with vidas? Rub igg ii (reference 30221). The patient is a pregnant woman and the vaccinated status is unknown. One sample was taken and the test result is as follows: on (b)(6) 2017: vidas? Rub igg result at iu/ml -> negative. On (b)(6) 2018 cobas? Roche rub igg technique result at 20. 5 iu/ml -> positive (tested by reference laboratory). On (b)(6) 2018: new patient sample tested with vidas? Rub iggii in duplicate and both results were negative. 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 | 3002769706-2018-00050 |
| MDR Report Key | 7403903 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-06 |
| Date of Report | 2018-07-12 |
| Date Mfgr Received | 2018-06-15 |
| Device Manufacturer Date | 2017-09-22 |
| Date Added to Maude | 2018-04-06 |
| 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 RD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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? RUB IGG II |
| Generic Name | VIDAS? RUB IGG II |
| Product Code | LFX |
| Date Received | 2018-04-06 |
| Catalog Number | 30221 |
| Lot Number | 1005974740 |
| Device Expiration Date | 2018-09-11 |
| 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 | 376, CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-06 |