MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-20 for VIDAS? CMV IGM 30205 manufactured by Biomerieux Sa.
[80826146]
Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[80826147]
A customer in (b)(6) notified biom? Rieux of (b)(6) results in association with vidas? (b)(6) (reference 30205) lot 1005685430. The patient is a woman, pregnant as of (b)(6) 2017, with (b)(6) results. On (b)(6) 2017, patient sample was tested and (b)(6) result at 0. 60 was obtained. On (b)(6) 2017, the patient's sample was retested three times and obtained (b)(6) results at 1. 06, 1. 02 and 1. 04. The sample was sent to biomnis for confirmation, and biomnis gave a (b)(6) result. A (b)(6) avidity test was performed and a obtained low avidity result. The (b)(6) result from (b)(6) 2017 was reported to the physician. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00194 |
| MDR Report Key | 6729872 |
| Date Received | 2017-07-20 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-06-21 |
| Date Mfgr Received | 2017-07-25 |
| Device Manufacturer Date | 2017-05-15 |
| Date Added to Maude | 2017-07-20 |
| 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 | MRS. 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, 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? CMV IGM |
| Generic Name | VIDAS? CMV IGM |
| Product Code | LKQ |
| Date Received | 2017-07-20 |
| Model Number | 30205 |
| Lot Number | 1005685430 |
| Device Expiration Date | 2017-03-20 |
| 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 | CHEMIN DE L ORME MARCY L ETOILE, 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-20 |