MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-31 for VYSIS ALK BREAK APART FISH PROBE KIT 06N38-20 manufactured by Abbott Molecular, Inc..
[24645810]
Elevated complaint investigation (ecinv) (b)(4) is in process for mdr 3005248192-2015-00017. An mdr follow-up report will be submitted after (b)(4) concludes.
Patient Sequence No: 1, Text Type: N, H10
[24645811]
The vysis alk break apart fish probe kit is 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). Patient result was negative by fish but ngs (next generation sequencing) demonstrated a myt1l-alk fusion product. The alk fusion to mytl1 gene identified by ngs is an apparent novel gene fusion not previously identified in the literature. The customer acknowledged that the pre-treatment conditions were not followed per the vysis alk break apart fish probe kit labeling. No death or serious injury was reported. An abbott molecular complaint investigation is in progress.
Patient Sequence No: 1, Text Type: D, B5
[34415806]
Summary of elevated complaint investigation (ecinv) (b)(4) for mdr 3005248192-2015-00017 follow-up report 1: investigation into this complaint included testing of the abbott molecular (am) retention samples from the lots of material in question, an evaluation of the quality data review and complaint history review. The results of the investigation are summarized as follows: quality data review: batch records (related manufacturing procedures and quality test records) were reviewed. No errors were identified. Verified that product met specifications at the time of release. Specifications include, but are not limited to, cytogenetic verification of probes, tissue integrity and functional parameters (intensity, background, cross-hybridization, specificity and counterstain quality). Product/system/instrument - retain and / or file sample evaluation: retain / file sample evaluation: retain sample: lsi alk dc bap ffpe fish probe-ivd: part #31-190068/ lot# 457151 (used in kit lot 457712 in question) was tested. The retention sample passed quality specifications. Specifications include, but are not limited to, cytogenetic review, tissue integrity and functional parameters (intensity, background, cross-hybridization, specificity and counterstain quality). Probechek alk negative control slides, paraffin embedded tumor lung biopsy specimens and male lymphocyte specimens were used for hybridization as required by the quality procedure. All slides were reviewed using the required dapi, orange specific, green specific and dapi/orange/green v. 2 filters when evaluating assay. A manual overnight hybridization and aqueous wash format was performed for the male lymphocyte assay. An overnight thermobrite (automated) assay and aqueous wash format was used for the pretreated probechek alk negative control slides and paraffin embedded tumor lung biopsy specimens. Cytogenetic verification of probes, tissue integrity and functional assay parameters (intensity, background, cross-hybridization, specificity and counterstain quality) passed all quality specifications. As a result of the am retain testing, there is nothing to indicate that performance was an issue as reported by the customer. Complaint history review: no additional related complaints were identified. Product deficiency decision: based on the results of the investigation elements, a product deficiency for the lsi alk dc bap ffpe fish probe-ivd: part #31-190068/lot# 457151 (used in kit lot 457712) was not identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2015-00017 |
| MDR Report Key | 4956796 |
| Date Received | 2015-07-31 |
| Date of Report | 2015-09-04 |
| Date of Event | 2015-07-02 |
| Date Mfgr Received | 2015-08-20 |
| Date Added to Maude | 2015-07-31 |
| 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 | 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 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600183315 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VYSIS ALK BREAK APART FISH PROBE KIT |
| Generic Name | IVD COMPANION DIAGNOSTIC DEVICE |
| Product Code | OWE |
| Date Received | 2015-07-31 |
| Catalog Number | 06N38-20 |
| Lot Number | 457712 |
| 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 EAST TOUHY AVENUE DES PLAINES IL 600183315 US 600183315 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-31 |