MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. VYSIS LSI IGH/CCND1 XT DUAL COLOR DUAL FUSION PROBES; REAGENTS, SPECIFIC, ANALYTE

Catalog Number 05J72-001

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2018

Event Type  malfunction  

Manufacturer Narrative

Complaint investigation has been initiated.Note: lot, expiration, udi, manufacture date and pma number have been left blank as this mdr is being submitted on the basis that vysis igh/ccnd1 xt df fish probe kit, list number 05n33-20 is similar to us fda approved analyte specific reagent, vysis lsi igh/ccnd1 xt dual color dual fusion probes, list number 05j72-001.Ticket does not reference a us list 05j72-001 lot number.

Event Description

The customer received 1 vysis igh/ccnd1 xt df fish probe kit (05n33-20) in their shipment that is damaged.The kit in question was found on dry ice in the styrofoam box, and the customer stated the kit was not separated by the cardboard that they usually receive items in.The vysis probe vial and the hybridization buffer tubes in the pack are damaged where the skirting of the tube was shattered.The content of the reagent was not affected, and no leakage was observed.Labels of both of the tubes had fallen off.The exterior of the styrofoam was not damaged.Since the broken bottles were found still inside the vysis probe box, molecular application specialist confirmed with the customer that they were not injured by the broken bottles.A replacement kit was delivered to the customer.This medical device report (mdr) is submitted on the basis that if this observation was caused by an abbot product malfunction and that malfunction were to recur, a shattered tube skirt has the potential to cause or contribute to serious injury or death.No patient was involved.The observation was made by the individual unpacking the reagent order.This incident is being reported to fda because the incident occurred in (b)(6) when receiving vysis igh/ccnd1 xt df fish probe kit, list number 05n33-20, which is similar to us fda approved analyte specific reagent, vysis lsi igh/ccnd1 xt dual color dual fusion probes, list number 05j72-001.

Manufacturer Narrative

Investigation into this complaint included an evaluation of the quality data review (device history record (dhr) review and capa review), retain evaluation, customer provided image evaluation and complaint history review.The results of the investigation are summarized as follows: the device history record/batch record review identified no issues or errors.The product under investigation met specifications at the time of release.The capa/non-conformance review searched for records related to vysis igh/ccnd1 xt df fish probe kit (lot# 486090) and reagents (lot# 484314 and 483789) used to manufacture the kit in question.Any resulting capa were then reviewed to determine relevance to this investigation.No records were identified as being related to this event.The complaint history review searched for complaints reporting damage in reference to vysis igh/ccnd1 xt df fish probe kit (lot# 486090) and reagents used (lot# 484314 and 483789) to manufacture the kit in question.No additional related complaints were identified.Retain/file sample evaluation: a visual inspection using the am retain sample from the same lots of material in question was performed to determine if products had any visually identifiable damage.No damage was identified.The customer's sample was not available for this investigation.The customer provided images were reviewed and no systemic issue was confirmed.Based on the results of the investigation elements, no product deficiency has been identified for vysis igh/ccnd1 xt df fish probe kit: list# 05n33-020/lot# 486090.The customer reported the event post shipment and handling.There have been no other reported complaints related to the lot of material in question and no other element of the investigation suggests a systemic issue.

• Brand Name: VYSIS LSI IGH/CCND1 XT DUAL COLOR DUAL FUSION PROBES
• Type of Device: REAGENTS, SPECIFIC, ANALYTE
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• MDR Report Key: 7986615
• MDR Text Key: 126222267
• Report Number: 3005248192-2018-00015
• Device Sequence Number: 1
• Product Code: MVU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 05J72-001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 10/19/2018
• Supplement Dates Manufacturer Received: 11/07/2018
• Supplement Dates FDA Received: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1