MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-02-03 for CELLESTIS 0592-0601 manufactured by Cellestis, Inc..
[37438821]
As part of a capa investigation, it was determined that complaint number (b)(4) is related to a foreign recall of a product only available in (b)94). Due to the similarity to a u. S product, in an abundance of caution, qiagen is filing a report.
Patient Sequence No: 1, Text Type: N, H10
[37438822]
Customer complaint received stating high rate of positive and grey-zone results for recruit tb screening tests seen at 2 sites.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122376-2016-00009 |
| MDR Report Key | 5408534 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-03 |
| Date of Report | 2016-02-02 |
| Date of Event | 2013-04-03 |
| Date Mfgr Received | 2013-04-15 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2016-02-03 |
| 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. DONNA SOWERS |
| Manufacturer Street | 28358 CONSTELLATION ROAD UNIT 698 |
| Manufacturer City | VALENCIA CA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal | 91355 |
| Manufacturer Phone | 2406867876 |
| Manufacturer G1 | QIAGEN LLC |
| Manufacturer Street | 19300 GERMANTOWN RD. |
| Manufacturer City | GERMANTOWN MD 20874 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 20874 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELLESTIS |
| Generic Name | QUANTIFERON TB GOLD |
| Product Code | NCD |
| Date Received | 2016-02-03 |
| Catalog Number | 0592-0601 |
| Lot Number | A1210004 |
| Device Expiration Date | 2014-01-01 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELLESTIS, INC. |
| Manufacturer Address | 28358 CONSTELLATION ROAD UNIT 698 VALENCIA CA 91355 US 91355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-03 |