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 2015-12-22 for VIDAS? TESTOSTERONE II 414320 manufactured by Biomerieux Sa.
[34133025]
A customer in (b)(6) reported different calibration test results after testing twice when using vidas testosterone ii ref: (b)(4) lot 1004052240 expiry date: 08/16/2016. Although ref (b)(4) is not sold within the united states, a similar product, ref (b)(4), is sold within the united states. There were no reports of patient harm. An investigation will be conducted into this incident.
Patient Sequence No: 1, Text Type: D, B5
[38313175]
An investigation into a discrepant calibration result with the vidas? Testosterone ii kit was performed. The customer did not return affected kit; therefore it was unable to be tested. A retain sample from the same lot was tested. This testing resulted in successful calibration results of s1= 1788 rfv and s1 = 1793 rfv. A manufacturing batch record review was performed and revealed no associated incidents or anomalies. Additionally, a complaint analysis for this lot was performed and revealed no other reported complaints. Based on the results of the investigation, the customer's complaint cannot be confirmed. The vidas? Testosterone ii kit is performing as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00173 |
| MDR Report Key | 5318618 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-12-22 |
| Date of Report | 2015-11-29 |
| Date Mfgr Received | 2015-11-29 |
| Device Manufacturer Date | 2015-06-11 |
| Date Added to Maude | 2015-12-22 |
| 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, S.A. |
| 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? TESTOSTERONE II |
| Generic Name | VIDAS? TESTOSTERONE II |
| Product Code | CDZ |
| Date Received | 2015-12-22 |
| Catalog Number | 414320 |
| Lot Number | 1004052240 |
| Device Expiration Date | 2016-08-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-12-22 |