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 2016-12-16 for VIDAS CMV IGG 30204 manufactured by Biomerieux Sa.
[62544572]
A customer in (b)(6) notified biom? Rieux of discrepant results associated with the vidas? Cmv igg. The customer reported that on (b)(6) 2016, they observed a quality control (qc) out of range when using the vidas? Cmv igg. Following this, the customer tested a known positive patient serum sample. The result shifted from positive to equivocal. Patient sample: test 1 - result 8ua/ml positive; test 2 - result 5 ua/ml equivocal. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[65938487]
A customer in (b)(6) notified biom? Rieux of discrepant results associated with vidas? Cmv igg. An internal biom? Rieux investigation was conducted. The analysis of the quality and batch records for vidas? Cmv igg lot 1005099130/170705-0 showed no other complaints, issues or nonconformities in association with the lot. A test was conducted for 8 internal samples on vidas? Cmv igg lot 1005099130/170705-0. All samples conformed to the expected results and specifications. A review of quality control records on several batches of vidas? Cmv igg showed all samples are within the expected ranges, and lot 170705-0 is in the trend as the other lots. The instructions for use (package insert) indicate the following: -it is recommended to confirm equivocal results using a second sample. -the vidas? Cmvg assay results should be interpreted taking into account the clinical symptoms and the medical analysis results from other tests (e. G. Detection of anti-cmv igm in case of primary infection). The investigation concluded the vidas? Mv igg lot 1005099130/170705-0 performed as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00520 |
| MDR Report Key | 6180566 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-16 |
| Date of Report | 2016-11-24 |
| Date of Event | 2016-11-24 |
| Date Mfgr Received | 2016-11-24 |
| Date Added to Maude | 2016-12-16 |
| 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 | ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS 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 |
| Manufacturer Postal Code | 69280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS CMV IGG |
| Generic Name | VIDAS CMV IGG |
| Product Code | LFZ |
| Date Received | 2016-12-16 |
| Catalog Number | 30204 |
| Lot Number | 1005099130 |
| Device Expiration Date | 2017-07-05 |
| 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 | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-16 |