MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. PROBECHECK ALK POSITIVE CONTROL SLIDES; MICROSCOPIC CONTROL SLIDES USED IN FISH TESTING

Catalog Number 06N38-10

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 07/12/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

The probechek 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 (list no.(b)(4).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.A customer reported that 2 out of 5 probechek alk negative control slides were received broken.There was no report of injury.The probecheck alk negative control slide package insert indicates these slides contain human sourced and/or potentialy infectious components.If this event were to recur, it is possible customers could cut themselves with a potentially infectious slide.

Manufacturer Narrative

Corrected name of product from "probechek alk negative control slides" to "probechek alk positive control slides".Summary of complaint investigation for mdr 3005248192-2016 follow-up report 1: investigation into this complaint included an evaluation of the quality data review, complaint history review, and retain sample evaluation.Quality data review device history record / batch record review: no errors/issues were identified.Product under investigation met quality specifications at the time of release.Process review indicated slides are inspected at regular intervals for damage in the manufacturing process and that slides are packed and shipped sufficiently to minimize damage.Complaint history review: products are individually qualified by lot.This is the first complaint for the lot of material in question.Product/system/instrument evaluation - retain and / or file sample evaluation: customer samples were not available for investigation: retain material was inspected for any visible signs of damage to the slide case (outer packaging) or to the slides themselves.No physical damage was identified.Product deficiency decision: based on the results of the investigation elements, a product or systemic deficiency for probechek alk positive control slides has not been identified.

Event Description

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 fish probe kit.A customer reported that 2 out of 5 probechek alk positive control slides were received broken.There was no report of injury.The probecheck alk positive control slide package insert indicates these slides contain human sourced and/or potentially infectious components.If this event were to recur, it is possible customers could cut themselves with a potentially infectious slide.

• Brand Name: PROBECHECK ALK POSITIVE CONTROL SLIDES
• Type of Device: MICROSCOPIC CONTROL SLIDES USED IN FISH TESTING
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 east touhy avenue; des plaines IL 60018 3315
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 east touhy avenue; des plaines IL 60018 3315
• Manufacturer Contact: kathleen zeng ; 1300 east touhy avenue; des plaines, IL 60018-3315 ; 2243617212
• MDR Report Key: 5864091
• MDR Text Key: 51874652
• Report Number: 3005248192-2016-00005
• Device Sequence Number: 1
• Product Code: OWE
• UDI-Device Identifier: 00884999025738
• UDI-Public: (01)00884999025738(17)161113(10)465684
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P110012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 06N38-10
• Device Lot Number: 465684
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1