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

Catalog Number	05J70-01
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation has been initiated.
Event or Problem Description
The customer reported that the abbott molecular fish vysis probe vial arrived crushed inside the shipping box, and the product was not usable.The outer shipping box was intact, and no outside box damage was observed.The probe packaging was intact, and there was a large piece of ice on top of the package.The broken vial was inside the package.The customer used ppe (personal protective equipment) when opening the shipment.There was no injury caused by the broken plastic probe vial.
Additional 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: quality data review: 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 lsi pml/rara dc df fish probe kit (lot# 492875) and probe (lot# 492388) 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.Product/system/instrument evaluation: retain / file sample evaluation: a visual inspection using the am retain sample from the same lot of material in question was performed to determine if products had any visually identifiable damage.No damage was identified.Return sample evaluation: the customer's sample was not available for this investigation.The customer-provided image was reviewed, and no systemic issue was confirmed.The complaint history review searched for complaints reporting damaged in reference to vysis lsi pml/rara dc df fish probe kit (lot# 492875) and probe used (lot# 492388) to manufacture the kit in question.No additional related complaints were identified.Based on the results of the investigation elements, no product deficiency has been identified for vysis lsi pml/rara dc df fish probe kit: list# 05j70-001 /lot# 492875.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 PML/RARA DUAL COLOR/DUAL FUSION PROBES
• Common Device Name: REAGENTS, SPECIFIC, ANALYTE
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• MDR Report Key: 8724041
• Report Number: 3005248192-2019-00005
• Device Sequence Number: 16565492
• Product Code: MVU
• UDI-Device Identifier: 00884999012325
• UDI-Public: 00884999012325
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: 510(K)EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2019

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
• Operator of Device: No Information
• Device Expiration Date: 01/03/2021
• Device Catalogue Number: 05J70-01
• Device Lot Number: 492875
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1