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 T0592-0201 manufactured by Cellestis Inc.
[37537389]
As a result of a capa investigation, historical complaints were found that were identified as requiring a medwatch report. The company has decided to submit this mdr for information purposes to ensure full compliance with 21cfr part 803. Cellestis filed notification of their voluntary recall through the regional fda district recall office on 16oct2012. Closure of the recall by the fda was received 25apr2013.
Patient Sequence No: 1, Text Type: N, H10
[37537390]
Cellestis customer complaint (b)(4) received stating that a patient tested positive and upon re-test one month later was negative. The customer is concerned that their general false positive rate is at (b)(6) in accordance with their results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122376-2016-00004 |
| MDR Report Key | 5408486 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-03 |
| Date of Report | 2016-02-02 |
| Date of Event | 2012-08-08 |
| Date Mfgr Received | 2012-08-08 |
| Device Manufacturer Date | 2011-11-01 |
| 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 | 19300 GERMANTOWN ROAD |
| Manufacturer City | GERMANTOWN MD 20874 |
| Manufacturer Country | US |
| Manufacturer Postal | 20874 |
| Manufacturer Phone | 2406867876 |
| Manufacturer G1 | CELLESTIS INC |
| Manufacturer Street | 28358 CONSTELLATION ROAD UNIT 698 |
| Manufacturer City | VALENCIA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91355 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 3003964343-01/28/13-001R |
| 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 | T0592-0201 |
| Lot Number | A111103N |
| Device Expiration Date | 2013-02-28 |
| 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 |