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 2019-03-29 for VIDAS? RUB IGG II 30221 manufactured by Biomerieux Sa.
[146239209]
A customer from (b)(6) notified biom? Rieux of obtaining a false negative result for a (b)(6)survey when testing with the vidas? Rubella igg ii assay (ref 30221). The result obtained for the sample with the vidas rubella igg ii assay was 9 iu/ml (< 10 iu/ml is interpreted as negative). The expected result for this survey was positive (presence of anti-rubella igg antibodies). It should be noted that for the majority of vidas users, customers reported the correct answer, with the distribution noted as follows: 95. 4% reported present (167 out of the 175 vidas participants), 2. 9% reported indeterminate (5 participants), 1. 7% reported absent (3 participants including this customer). As there is no patient associated with this quality control strain, there is no 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 | 8020790-2019-00023 |
| MDR Report Key | 8466190 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-29 |
| Date of Report | 2019-05-27 |
| Date Mfgr Received | 2019-05-03 |
| Device Manufacturer Date | 2018-07-05 |
| Date Added to Maude | 2019-03-29 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CANDACE MARTIN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 69280, |
| Manufacturer Country | FR |
| 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 | 2019-03-29 |
| Catalog Number | 30221 |
| Lot Number | 1006620930 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280, FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-29 |