MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2015-08-14 for DAKO IR055 manufactured by Dako North America, Inc.
[23089775]
On (b)(6) 2015, dako received a complaint regarding the routine use of the flex monoclonal mouse anti-human wilms' tumor 1 (wt1) protein clone 6f-h2 on the autostainer link 48 for diagnostic use. Initially the customer reported false positive staining, claiming that this staining contributed to a diagnostic error leading to distress, unnecessary surgery and other incorrect treatment. On august 12, 2015, dako received follow up information regarding this incident. The customer reported that they have revalidated the same batch of wt1 used in the original testing and have confirmed expected staining results. The customer reported that a retest was also carried out at another laboratory, on sections from the same biopsy, and results were also positive. The customer reported that a separate test can on surgical test resection tissue done at another hospital was negative. The customer reported that as a result of these conclusions, the customer has informed dako that they are no longer pursuing a complaint about dako regarding false positive staining with the wt1 antibody. Dako is in the process of obtaining details of this complaint for further investigation.
Patient Sequence No: 1, Text Type: D, B5
[35017446]
Follow-up: after further investigation, dako has discovered that the problem complaint described in this mdr, 2022180-2015-0002, had nothing to do with the wt1 antibody. The issue was discovered to be related to the envision flex+ product problem that was outlined in mdr 9610099-2015-2015. This investigation is closed.
Patient Sequence No: 1, Text Type: N, H10
[35017447]
Please see additional manufacture narrative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022180-2015-00002 |
| MDR Report Key | 5004603 |
| Report Source | FOREIGN |
| Date Received | 2015-08-14 |
| Date of Report | 2015-11-03 |
| Date Mfgr Received | 2015-07-16 |
| Device Manufacturer Date | 2014-03-27 |
| Date Added to Maude | 2015-08-14 |
| 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 | ASHLEIGH DAWLEY |
| Manufacturer Street | 6392 VIA REAL |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal | 93013 |
| Manufacturer Phone | 8055663072 |
| Manufacturer G1 | DAKO NORTH AMERICA, INC |
| Manufacturer Street | 6392 VIA REAL |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAKO |
| Generic Name | FLEX MONOCLONAL MOUSE (WT1) PROTEIN CLONE 6F-H2, RTU, LINK |
| Product Code | NJT |
| Date Received | 2015-08-14 |
| Model Number | IR055 |
| Catalog Number | IR055 |
| Lot Number | 10086975 |
| Device Expiration Date | 2015-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAKO NORTH AMERICA, INC |
| Manufacturer Address | 6392 VIA REAL CARPINTERIA CA 93013 US 93013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-14 |