MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2012-12-05 for ULTRAVIEW UNIVERSAL DAB DTECTION KIT 760-500 manufactured by Ventana Medical Systems, Inc..
[2961999]
A customer in (b)(6) reported that they discovered that a dispenser of hrp multimer reagent within a ultraview universal dab detection kit had a higher volume of reagent than other dispensers in the detection kit after using the kit for approximately 2 weeks and generating 211 tests. The customer examined the hrp multimer dispenser and reported that it was not dispensing properly. This customer does not use positive run controls, as is required in the package insert. Therefore, the customer was unsure when the dispensing issue may have started and whether any results originally reported as negative were false. The customer retested all of the tissue specimens that stained negative on the original runs and found that three results restained as positive. This report is associated with one of those results. The patient tissue in this case was tested using an anti-p16 marker and the customer indicates that original false negative result reported to the physician did result in a misdiagnosis. There is no information about impact to patient health available as of the date of this report. The intended use of ventana ultraview universal dab detection kit follows: ventana medical systems' (ventana) ultraview universal dab detection kit is an indirect, biotin-free system for detecting mouse igg, mouse igm and rabbit primary antibodies. The kit is intended to identify targets by immunohistochemistry (ihc) in sections of formalin-fixed, paraffin-embedded and frozen tissue that are stained on the benchmark, benchmark xt, and benchmark ultra instruments. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This product is intended for in vitro diagnostic (ivd) use.
Patient Sequence No: 1, Text Type: D, B5
[10262367]
The current package insert for the ultraview universal dab detection kit includes the following instructions for use regarding positive controls: quality control procedures; positive tissue control; optimal laboratory practice is to include a positive control section on the same slide as the patient tissue. When this practice is employed, identification of a failure to apply primary antibody or other critical reagent to the patient test slide is easily detected. Additionally, positive controls should be selected on the basis of expression of the antigen. Low levels of antigen expression are suggested to prevent false negative results due to insufficient sensitivity. A tissue with weak positive staining is more suitable for optimal quality control and for detecting minor levels of reagent degradation. A positive tissue control must be run with every staining procedure performed. Optimal laboratory practice is to include a positive control section on the same slide as the patient tissue. This practice helps to identify a failure to apply primary antibody or other critical reagent to the patient test slide. A tissue with weak positive staining is more suitable for optimal quality control. The positive staining tissue components are used to confirm that the antibody was applied and the instrument functioned properly. This tissue may contain both positive and negative staining cells or tissue components and serve as both the positive and negative control tissue. Control tissues should be fresh autopsy, biopsy, or surgical specimens prepared or fixed as soon as possible in a manner identical to the test sections. Such tissues may monitor all steps of the procedure from tissue preparation through staining. Use of a tissue section fixed or processed differently from the test specimen will provide control for all reagents and method steps except fixation and tissue processing. Known positive tissue controls should be utilized only for monitoring the correct performance of processed tissues and test reagents, not as an aid in determining a specific diagnosis of patient samples. If the positive tissue controls fail to demonstrate positive staining, results with the test specimens should be considered invalid. It is confirmed that the customer was not using same slide positive tissue controls or positive tissue run controls. The hrp multimer dispenser has been returned to ventana by the customer and examined in detail. A particulate extrinsic to ventana processes was discovered within the dispenser that resulted in an intermittent loss of prime. This material was identified as a red polycarbonate 0. 6 mm square in size. The supplier of the dispenser components used by ventana has been contacted and they have confirmed that they do manufacture red polycarbonate components for other customers. Ventana is reviewing existing and potential mitigations with the supplier to prevent recurrence of this type of incident. A follow-up report will be submitted if additional information is obtained.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028492-2012-00006 |
| MDR Report Key | 2858154 |
| Report Source | 01,06,07 |
| Date Received | 2012-12-05 |
| Date of Report | 2012-11-06 |
| Date of Event | 2012-10-23 |
| Date Mfgr Received | 2012-11-06 |
| Device Manufacturer Date | 2012-06-05 |
| Date Added to Maude | 2012-12-05 |
| 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 | MR. ROBERT BROOKS |
| Manufacturer Street | 1910 E. INNOVATION PARK DR. |
| Manufacturer City | TUCSON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5208777191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRAVIEW UNIVERSAL DAB DTECTION KIT |
| Generic Name | NJT |
| Product Code | NJT |
| Date Received | 2012-12-05 |
| Model Number | NA |
| Catalog Number | 760-500 |
| Lot Number | C03749 |
| Device Expiration Date | 2013-02-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTANA MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 1910 E. INNOVATION PARK DR. TUCSON AZ 85755 US 85755 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-12-05 |