MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-04-18 for PROBECHECK ALK NEGATIVE CONTROL SLIDES 06N38-005 manufactured by Abbott Molecular, Inc..
[10797724]
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Patient Sequence No: 1, Text Type: N, H10
[19365816]
The probecheck alk negative control slides are intended for use as an assay control for appropriate hybridization conditions during routine use of the vysis alk break apart fish probe kit, a qualitative test that detects rearrangements involving the alk gene via fish in formalin-fixed paraffin-embedded (ffpe) non-small cell lung cancer tissue specimens to aid in identifying those pts eligible for treatment with xalkori (crizotinib). The probecheck alk negative control slides should be assayed in conjunction with the user's specimen slides according to the package insert for the vysis alk break fish probe kit. A customer reported that probecheck alk negative control slides were broken upon receipt. There was no injury due to the broken slides.
Patient Sequence No: 1, Text Type: D, B5
[19446592]
The following warnings and precautions are listed in the probecheck alk negative control slides package insert (30-608496/r2): caution - this preparation contains human sourced components. No known test method can offer complete assurance that products derived from human sources will not transmit infection. Therefore, all human sourced materials should be considered potentially infectious. It is recommended that these reagents and human specimens be handled in accordance such as those outlined in osha standard on bloodborne pathogens. Biosafety level2 or other appropriate biosafety practices should be used for materials that contain or are suspected of containing infectious agents. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2012-00014 |
| MDR Report Key | 2708830 |
| Report Source | 07 |
| Date Received | 2012-04-18 |
| Date of Report | 2012-03-29 |
| Date of Event | 2012-03-29 |
| Date Mfgr Received | 2013-05-14 |
| Date Added to Maude | 2012-09-12 |
| 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 | JEAN LEETE |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal | 600183315 |
| Manufacturer Phone | 2123617274 |
| 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 | PROBECHECK ALK NEGATIVE CONTROL SLIDES |
| Generic Name | MICROSCOPIC CONTROL SLIDES USED IN FISH TESTING |
| Product Code | OWE |
| Date Received | 2012-04-18 |
| Catalog Number | 06N38-005 |
| Lot Number | 438123 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2012-04-18 |