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..
[37437422]
As part of a capa investigation, it was determined that complaint number 172032-49483 is related to a foreign recall of a product only available in (b)(4). Due to the similarity to a us product, in an abundance of caution, qiagen is filing a report.
Patient Sequence No: 1, Text Type: N, H10
[37437423]
Customer complaint received reporting high rate of positive and grey zone results for recruit tb screening at hospital.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1122376-2016-00008 |
MDR Report Key | 5408516 |
Report Source | USER FACILITY |
Date Received | 2016-02-03 |
Date of Report | 2016-02-02 |
Date of Event | 2013-04-05 |
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 ROAD |
Manufacturer City | GERMANTOWBN 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 |