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 2016-02-24 for VIDAS? CMV IGG 30204 manufactured by Biomerieux Sa.
[38863164]
A customer in (b)(6) reported to biom? Rieux that they experienced a false negative when using the vidas? Cmv igg test. The customer retested the sample and produced the correct result. When specifically requested, the customer indicated there was no impact to patient or patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[87004992]
A customer in (b)(6) reported to biom? Rieux that they experienced a (b)(6) when using the vidas? Cmv igg test. An internal biom? Rieux investigation was performed.
Patient Sequence No: 1, Text Type: N, H10
[87028235]
An internal biom? Rieux investigation was performed with results as follows: no anomaly was observed during a review of biom? Rieux internal quality records. A visual inspection was performed on a retained kit of vidas? Cmvg lot 1004170210 and no anomaly was observed. (b)(6) samples were tested on the retained kit of vidas? Cmvg lot 1004170210. The results obtained for the five samples were within specification. The results on the control card for these five samples shows that vidas? Cmvg lot 1004170210/160531-0 is in the trend on the other batches. According to an internal error table, if the customer forgets a sample or a solid phase receptacle (spr) during the analysis, it can cause a negative signal (rfv less than 0). Based on the internal record review, the likely cause of this event is the customer forgetting to put the sample on the strip or they forgot to add the spr. The investigation concluded the vidas? Cmv igg lot 1004170210 performed as expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00037 |
| MDR Report Key | 5456352 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-24 |
| Date of Report | 2017-06-14 |
| Date Mfgr Received | 2016-03-02 |
| Date Added to Maude | 2016-02-24 |
| 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 | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| 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 | 2016-02-24 |
| Catalog Number | 30204 |
| Lot Number | 1004170210 |
| Device Expiration Date | 2016-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-02-24 |