MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-10-10 for PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT 02J27-011 manufactured by Abbott Molecular, Inc..
[3881978]
The probechek urovysion control slides are non-hybridized slides prepared with cultured normal male lymphoblast cells and cultured bladder cancer cell lines. Each control slide consists of two separate target areas in which each of the different cell types have been applied. The cell lines are harvested, fixed in suspension medium and applied to the glass microscope slides in a method optimal for fish (fluorescence in situ hybridization). A customer at (b)(6) medical center in (b)(6) reported that one of three slides in a probechek urovysion bladder kit control slides package was broken upon receipt. There was no report of injury. The probechek urovysion bladder kit control slides package insert indicates that these slides contain human sourced and/or potentially infectious components. If the issue of customers receiving broken probechek slides were to recur, it is possible that customers could cut themselves with a potentially infectious slide. Therefore, recurrence of this issue could potentially cause or contribute to serious injury or death.
Patient Sequence No: 1, Text Type: D, B5
[11148101]
The following warnings and precautions are listed in the probechek urovysion control slide package insert, 30-608394 / r2: warnings and precautions, in vitro diagnostic medical device: all biological specimens should be treated as if capable of transmitting infectious agents. The probecheck control slides recommended for use with this kit are manufactured from human cell lines that have been fixed in carnoy's fixative. Because it is often impossible to know which might be infectious, all human specimens and control slides should be treated with universal precautions. Guidelines for specimen handling are available from the u. S. Centers for disease control and prevention. Avoid contact of probechek control slides with skin and mucous membranes. Caution: this article contains human sourced and / or potentially infectious components. No known test method can offer complete assurance that products derived from human sources or inactivated microorganisms will not transmit infection. These reagents and human specimens should be handled as if infectious using safe laboratory procedures, such as those outlined in biosafety in microbiological and biomedical laboratories, osha standards on bloodborne pathogens, clsi document m29-a3, and other appropriate biosafety practices. Therefore, all human sourced materials should be considered infectious. These precautions include, but are not limited to, the following: wear gloves when handling specimens or reagents. Do not pipette by mouth. Do not eat, drink, smoke, apply cosmetics, or handle contact lenses in areas where these materials are handled. Clean and disinfect spills of specimens by including the use of a tuberculocidal disinfectant such as 1. 0 % sodium hypochlorite or other suitable disinfectant. Decontaminate and dispose of all potentially infectious materials in accordance with local, state, and federal regulations. Summary of complaint investigation: the investigation into this complaint included an evaluation of the device history record (dhr) review, inspection of abbott molecular retain samples and capa and complaint history review. The results of the investigation are summarized as follows: batch record (dhr) review did not identify any issues related to broken slides for the lots of material currently under investigation. No lot specific and/or systemic issues have been identified. Current manufacturing procedures address inspection prior to shipment. Additionally, current abbott molecular shipping procedures adequately address shipping conditions. A lot specific capa search was performed for impacted lots of material to determine if any lot specific issues have been identified. Search did not identify any exceptions related to damaged material / product for this lot of material. An additional capa search was performed for the past 12 months for all microscope slides shipped by abbott molecular. Search did not identify exceptions related to damaged material / product during this time frame. Complaint search was performed for all control slides shipped by abbott molecular over the past 12 months. A complaint rate for all fish slides was calculated as 0. 028%, with the frequency determined as occasional. Abbott molecular does not request broken slides to be returned by customers and no pictures of broken slides were provided by customers. Retain sample kits from the lots of material in question were inspected to identify any systemic internal damage issue occurring prior to shipment. Retain samples continue to meet specifications and no specific issues with regards to broken slides were identified. In summary, the complaint investigation did not confirm this complaint. No product deficiency was identified based on elements of this investigation. Current manufacturing and shipping procedures adequately address inspection and protective packaging and shipping. The complaint frequency is less than 1% over the last year (september 2012- september 2013). Investigated w/o device returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2013-00013 |
| MDR Report Key | 3405484 |
| Report Source | 07 |
| Date Received | 2013-10-10 |
| Date of Report | 2013-09-26 |
| Date of Event | 2013-09-24 |
| Date Mfgr Received | 2013-09-24 |
| Date Added to Maude | 2014-01-13 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JEAN LEETE |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617274 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT |
| Generic Name | MICROSCOPIC CONTROL SLIDES USED IN FISH TESTING |
| Product Code | NSD |
| Date Received | 2013-10-10 |
| Catalog Number | 02J27-011 |
| Lot Number | 444935 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 EAST TOUHY AVENUE DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-10 |