MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-26 for PROBECHEK ALK POSITIVE CONTROL SLIDES 06N38-10 manufactured by Abbott Molecular, Inc..
[101250264]
Investigation is in process.
Patient Sequence No: 1, Text Type: N, H10
[101250265]
The probechek alk positive 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 (list no. 06n38). The probechek alk positive control slides should be assayed in conjunction with the user's specimen slides according to the package insert for the vysis alk break apart fish probe kit (list no. 06n38). Customer reported that when opening alk positive control slides one slide was broken. The customer did not report any injury. Lab technician was wearing protective equipment. The outer box appeared to be slightly recessed like pressure had been put on it. The probechek alk positive control slide package insert indicates these slides contain human sourced and/or infectious components. If this event were to recur, it is possible customers could cut themselves with a potentially infectious slide. There is no patient involved as the broken slide was observed during opening of the product by a laboratory technician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005248192-2018-00001 |
| MDR Report Key | 7298180 |
| Date Received | 2018-02-26 |
| Date of Report | 2018-03-15 |
| Date of Event | 2018-01-30 |
| Date Mfgr Received | 2018-02-27 |
| Device Manufacturer Date | 2017-09-05 |
| Date Added to Maude | 2018-02-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOE HUTSON |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal | 600183315 |
| Manufacturer Phone | 2243617619 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600183315 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROBECHEK ALK POSITIVE CONTROL SLIDES |
| Generic Name | FLUORESCENCE IN SITU HYBRIDIZATION, ANAPLASTIC LYMPHOMA KINASE, GENE REARRANGEME |
| Product Code | OWE |
| Date Received | 2018-02-26 |
| Catalog Number | 06N38-10 |
| Lot Number | 479393 |
| Device Expiration Date | 2018-08-07 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 E. TOUHY AVE. DES PLAINES IL 600183315 US 600183315 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-26 |