MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-03 for CELLESTIS T0590-0301 manufactured by Cellestis Inc.
[38236281]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[38236282]
Cellestic customer (b)(4) received where customer reported that they drew 5 samples on monday ((b)(6)) before training. During the first day of training , the samples were run and all resulted as positive. They stated that they had worked in many different labs in the hospitals and with lots of patients. That same day the samples were redrawn plus an additional 2 samples. They repeated as positive on the second day of training, with the additional 2 samples as negative. The validation samples that were supplied resulted as expected with a mixture of positives and negative results. The customer sent the 7 tubes that were drawn for the second day of testing to their lab in sioux falls, and they confirmed the positive and negative results. The customer then ordered a new tube lot and redrew the same 7 samples. They ran these samples in their lab and sent them to mayo to run. All are negative. They are convinced that it is the lot of tubes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122376-2016-00002 |
| MDR Report Key | 5408484 |
| Date Received | 2016-02-03 |
| Date of Report | 2016-02-02 |
| Date of Event | 2012-07-09 |
| Date Mfgr Received | 2012-07-09 |
| 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 |
| Manufacturer City | VALENCIA MD 01355 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 3003964343-01/28/13-001R |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CELLESTIS |
| Generic Name | QUANTIFERON TB GOLD |
| Product Code | NCD |
| Date Received | 2016-02-03 |
| Catalog Number | T0590-0301 |
| Lot Number | A111103N |
| Device Expiration Date | 2013-02-28 |
| 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 91355 US 91355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-03 |