MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-19 for VIDAS? RUB IGG II 30221 manufactured by Biomerieux Sa.
[103277207]
A customer from (b)(6) reported false positive results for a serological external quality control sample, from the eqa qcmd (b)(6) 2017 campaign, in association with the vidas? Rub igg ii assay (lot 1005490680). The qcmd testing scenario mentioned, "a stem cell transplant recipient is screened for immunity to several pathogens before transplantation. " the vidas rub igg result for sample qcmd4 was positive (15 iu/ml) while the expected result was equivocal. According to qcmd eqa report, participant results were: architect : positive result (30%) and negative result (70%). Vidas : positive result (100%). Siemens : positive result (100%). Diasorin : negative result (more than 60%) equivocal result (20%) and positive result (20%). A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00044 |
| MDR Report Key | 7349390 |
| Date Received | 2018-03-19 |
| Date of Report | 2018-06-05 |
| Date Mfgr Received | 2018-05-09 |
| Device Manufacturer Date | 2017-02-13 |
| Date Added to Maude | 2018-03-19 |
| 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 | 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 | 0 |
| Brand Name | VIDAS? RUB IGG II |
| Generic Name | VIDAS? RUB IGG II |
| Product Code | LFX |
| Date Received | 2018-03-19 |
| Catalog Number | 30221 |
| Lot Number | 1005490680 |
| Device Expiration Date | 2018-02-01 |
| 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 | 2018-03-19 |