MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-05-14 for PROBECHEK ALK NEGATIVE CONTROL SLIDES 06N38-005 manufactured by Abbott Molecular, Inc..
[3456165]
The probechek alk negative control slides (list no. 06n38-005) are intended for use as an assay control for appropriate hybridization conditions during routine use of the vysis alk break apart fish probe kit (list no. 06n38-020), a qualitative test to detect rearrangements involving the alk gene via fluorescence in situ hybridization (fish) in formalin-fixed paraffin-embedded (ffpe) non-small cell lung cancer (nsclc) tissue specimens to aid in identifying those patients eligible for treatment with xalkori (crizotinib). The probechek 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. The test is for prescription use only. A customer reported that probechek alk negative control slides were broken upon receipt. There was no report of injury due to the broken slides. The probechek alk negative control slides package insert indicates 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 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
[10764645]
The following warnings and precautions are listed in the probechek alk negative control slides package insert (30-608496/r3): caution: this preparation 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 material 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2013-00011 |
| MDR Report Key | 3112594 |
| Report Source | 07 |
| Date Received | 2013-05-14 |
| Date of Report | 2013-05-03 |
| Date of Event | 2013-05-03 |
| Date Mfgr Received | 2013-05-03 |
| Date Added to Maude | 2013-07-22 |
| 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 | 2243617274 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018331 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 3315 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROBECHEK ALK NEGATIVE CONTROL SLIDES |
| Generic Name | MICROSCOPIC CONTROL SLIDES USED IN FISH TESTING |
| Product Code | OWE |
| Date Received | 2013-05-14 |
| Catalog Number | 06N38-005 |
| Lot Number | 445366 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-05-14 |