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 2017-03-03 for VIDAS? CMV IGG ASSAY 30204 manufactured by Biom?rieux Sa.
[69110204]
A customer in (b)(6) notified biom? Rieux of discrepant results associated with vidas? Cmv igg (reference 30204) related to false positive results. The customer reported the dilution factors of 1:429 which accounts for the high results. There is no indication or report from the laboratory or physician that the discrepant result led to an adverse event related to a patient's state of health. No incorrect information was reported to the physician because the results were identified as incorrect immediately. The customer reported there was approximately half an hour delay reporting results. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[73719306]
An internal biom? Rieux investigation concluded the following: the analysis of the batch history records showed no anomaly. There was no capa, nor non conformity for a similar issue in relation to the customer's anomaly. There was no other complaint for the same issue on the batch vidas (b)(6) lot 1005287390/170920-0. On march 09th, the product quality laboratory tested three internal samples ((b)(6)) on the retained kit vidas (b)(6) batch 1005287390/170920-0 on vidas pc. (b)(6), (b)(6) sample, target 3. 1, the result was < 4 (b)(6). (b)(6), the same (b)(6) sample tested pure but with the dilution (1/428) entered in the vidas software. The result was (b)(6) (993 ua/ml). (b)(6), an equivocal sample, target 4. 18, the result found: 4 ua/ml equivocal.. (b)(6), a (b)(6) sample, tested pure the result was 176 ua/ml. (b)(6): the same (b)(6) sample tested pure but with the dilution (1/429) entered in the vidas software, the result was (b)(6) (77626 ua/ml). (b)(6): the same sample was tested with a manual dilution, the result is positive ( 232 ua/ml) consistent with the sample tested pure. The product quality laboratory reproduced the customer's anomaly. The concentrations are expressed in au/ml. Samples with (b)(6) concentrations > 400 au/ml should be reassayed after dilution by 1/4 in saline solution. If the dilution factor has not been entered when the work list was created (see user's manual), multiply the result by the dilution factor to obtain the sample concentration. For serological monitoring, to obtain an accurate serum titer, dilute the samples with concentrations > 150 au/ml in order to obtain a result ranging between 50-150 au/ml. Since no international standard is available for the determination of (b)(6), the vidas (b)(6) reagent is calibrated against collection sera. There is no drift linked to the reagent vidas (b)(6) lot 1005287390/170920-0.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2017-00042 |
| MDR Report Key | 6377068 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-03 |
| Date of Report | 2017-04-07 |
| Date Mfgr Received | 2017-03-14 |
| Date Added to Maude | 2017-03-03 |
| 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 ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | CHEMIN DE L ORME 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? CMV IGG ASSAY |
| Generic Name | VIDAS? CMV IGG ASSAU |
| Product Code | LFZ |
| Date Received | 2017-03-03 |
| Catalog Number | 30204 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-03 |