N
Patient 1
.
MAUDE MDR 2708830
- MDR report key
- 2708830
- Report number
- 3005248192-2012-00014
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-03-29
- Date received
- 2012-04-18
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- JEAN LEETE
- Address
- 1300 EAST TOUHY AVENUE DES PLAINES IL 60018 US
- Phone
- 212-212-2123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PROBECHECK ALK NEGATIVE CONTROL SLIDES | MICROSCOPIC CONTROL SLIDES USED IN FISH TESTING | ABBOTT MOLECULAR, INC. | OWE | 06N38-005 | 438123 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-04-18 | 0 |
Event Narratives#
D
Patient 1
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.
N
Patient 1
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.