MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. VYSIS LSI MDM2 SPECTRUMORANGE, 20 UL PROBE; REAGENTS, SPECIFIC, ANALYTE

Catalog Number 01N15-020

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

Elevated 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 lsi mdm2 so/cep 12 probe kit (list 01n15-10) is similar to vysis lsi mdm2 spectrumorange, 20 ul probe (list 01n15-020) sold in the united states.Ticket does not reference a us list 01n15-020 lot number.

Event Description

The customer received a vysis mdm2/cep12 fish probe kit and found the vial of the probe was shattered upon opening the package.The customer examined the outer package and found there was a folded wrinkle on the side of product package therefore suspecting that the package may have been pressed during transportation.The primary and secondary distributor claimed neither did they open the probe package nor notice signs of damage.The customer requested a replacement.There was no injury associated with the event.The user was wearing latex gloves when handling and opening the package.The customer noticed the folding in the packaging only after opening the kit when asked to check if there was damage on the package.The package folding was not noticeable prior to opening.This event did not involve a patient as it was identified by the user.This incident is being repoted to fda because the incident occurred in (b)(6) using the vysis lsi mdm2 so/cep 12 probe kit, list number 01n15-10, which is the same/ similar to the vysis lsi mdm2 spectrumorange, 20 ul probe, list number 01n15-020, which is registered with fda as an analyte specific reagent.

Manufacturer Narrative

Investigation into this complaint included an evaluation of the quality data review (device history record (dhr) review and capa review), abbott molecular (am) retain inspection, customer image review and complaint history review.The results of the investigation are summarized as follows: quality data review; device history record / batch record review.No issues or errors were identified.The product under investigation met specifications at the time of release.Capa / non-conformance review: each unique lot is individually qualified at kit lot manufacturing for the materials in question; therefore, the search was lot specific.All related material in question was accounted for in the search criteria.Any resulting capa were then reviewed to determine relevance to this investigation.No related capa were identified.Product/system/instrument evaluation: retain / file sample evaluation: an inspection using the am retain sample (quantity (qty.) 1) from the same lot of material in question was performed to determine if products had any obvious identifiable damage, including broken probe bottle.No damage was identified.Return sample evaluation: the customer's sample was not available for this investigation, however the customer provided images were reviewed.Complaint history review: a search for complaints reporting damaged in reference to vysis lsi mdm2 so/cep 12 sgn fish probe kit (lot# 502252) and probe used (lot# 501637) to manufacture the kit in question identified no additional complaints.Based on the results of the investigation elements, no product deficiency has been identified for vysis lsi mdm2 so/cep 12 sgn fish probe kit: list # 01n15-010/lot# 502252.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.Correction: on initial report, date received by manufacturer stated 07-jun-2020, but should have been 05-jun-2020.Quality assurance was made aware of this updated information on 26-jun-2020, which will serve as the date received by manufacturer for this final report.

• Brand Name: VYSIS LSI MDM2 SPECTRUMORANGE, 20 UL PROBE
• Type of Device: REAGENTS, SPECIFIC, ANALYTE
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines, il
• MDR Report Key: 10197662
• MDR Text Key: 230493599
• Report Number: 3005248192-2020-00024
• 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: 07/23/2020

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: 01N15-020
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/07/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1