MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-02-03 for CELLESTIS 0592-0601 manufactured by Cellestis Inc..
[37437588]
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)(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
[37437589]
Customer complaint received stating that the ratios of positive and gray zones were high in the medical checkups for 30 healthcare workers and 42 inpatients. Similar cases were seen in the same lot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122376-2016-00007 |
| MDR Report Key | 5408497 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-02-03 |
| Date of Report | 2016-02-02 |
| Date of Event | 2014-01-10 |
| Date Mfgr Received | 2013-04-08 |
| 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 | 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 |