MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-03-13 for UNIVERSAL IVIEW DAB 760-041 manufactured by Ventana Medical Systems, Inc..
[696839]
A trend in customer complaints revealed that the volume of dab component was not dispensing at the same levels as other reagents. Patient care was not affected. Of the returned kits examined there was a very low rate of particulates observed in the dab (chromogen) component. In a small number of cases the particulate could occlude the opening and result in inconsistent staining. Although none have been reported there is a possibility for a false negative if the dispenser is completely occluded or partially occluded causing inconsistent staining.
Patient Sequence No: 1, Text Type: D, B5
[7858909]
Other lots listed in the trend are lot number 513540 (expiration date of 2007/12/31) and lot number 515248 (expiration date of 2007/12/31) for product name iview dab detection. The firm will issue a customer communication to alert them of the particulates and remind customers of the inspection practices defined in the package insert. Due to the remote possibility of an erroneous but believable result the letter will ask the customer to look for any particulates in the listed lots of iview dab products and have them return any dispensers that appear suspect. The firm is also taking corrective and preventive action by replacing the sulfur cured o-ring with a peroxide cured o-ring which will help prevent future occurrences. The firm will also distribute a white paper that describes optimal lab practices. This paper references the college of american pathologists anatomic pathology checklist item anp. 22550 which states " a positive control section included on the same slide as the patient tissue is optimal practice because it helps identify failure to apply primary antibody or other critical reagents to the patient test slide.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028492-2007-00007 |
| MDR Report Key | 914302 |
| Report Source | 06 |
| Date Received | 2007-03-13 |
| Date of Report | 2007-01-24 |
| Date of Event | 2007-01-24 |
| Date Mfgr Received | 2007-02-13 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2007-09-18 |
| 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 | 0 |
| Manufacturer Contact | TOM MALONEY |
| Manufacturer Street | 1910 E INNOVATION PARK DRIVE |
| Manufacturer City | TUCSON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5202293848 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL IVIEW DAB |
| Generic Name | NJT |
| Product Code | NJT |
| Date Received | 2007-03-13 |
| Model Number | NA |
| Catalog Number | 760-041 |
| Lot Number | 512384 |
| ID Number | NA |
| Device Expiration Date | 2007-11-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 887363 |
| Manufacturer | VENTANA MEDICAL SYSTEMS, INC. |
| Manufacturer Address | * TUCSON AZ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-13 |