MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-06-04 for IVIEW DAB DETECTION KIT 760-091 manufactured by Ventana Medical Systems, Inc..
[639024]
The site discovered one case from last year that was reported positive for pth and calcitonin that in fact after running again with a/b blocker these test samples results were negative. The site had been running all negative controls with a/b block despite the fact that the test slides were not run with a/b block. The site described concern around other similar cases over the past year that may have been misdiagnosed as medullary thyroid carcinoma based on "positive" calcitonin results. The site acknowledged that this is a case of user error and understand the importance of subjecting the negative controls and test slides to the same analytic conditions. There is no evidence that this result was due to an instrument malfunction or reagent issue.
Patient Sequence No: 1, Text Type: D, B5
[7973108]
The site acknowledged that this is a case of user error and understands the importance of subjecting the negative controls and test slides to the same analytic conditions. There is no evidence that this result was due to an instrument malfunction or reagent issue. The site mentioned that they are amending a patient report and also mentioned that it did affect life expectancy reported to the patient and possibly the type of chemo therapy they were given. The site stated they did not want to release any other information about the patient. There will be no follow up report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028492-2007-00013 |
| MDR Report Key | 860735 |
| Report Source | 06 |
| Date Received | 2007-06-04 |
| Date of Report | 2007-05-07 |
| Date of Event | 2007-05-07 |
| Date Mfgr Received | 2007-05-09 |
| Device Manufacturer Date | 2007-02-01 |
| Date Added to Maude | 2007-06-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TOM MALONEY |
| Manufacturer Street | 1910 EAST INNOVATION PARK DR. |
| Manufacturer City | TUCSON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5202293848 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IVIEW DAB DETECTION KIT |
| Generic Name | IVIEW DAB DETECTION KIT |
| Product Code | NJT |
| Date Received | 2007-06-04 |
| Model Number | NA |
| Catalog Number | 760-091 |
| Lot Number | 524832 |
| Device Expiration Date | 2007-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 844699 |
| Manufacturer | VENTANA MEDICAL SYSTEMS, INC. |
| Manufacturer Address | TUCSON AZ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-06-04 |