MAUDE Adverse Event Report: ABBOTT MOLECULAR INC. PROBECHEK MULTIVYSION CONTROL SLIDES; GENERAL PURPOSE REAGENT

Catalog Number 05J07-01

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.

Event Description

(b)(4) distributor received slides from abbott molecular, they found that 1 box of the multivysion control slide was damaged.Based on the images provided, at least one slide appeared to be broken.There was no report of injury.The certificate of analysis for probechek multivysion control slides 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.

Manufacturer Narrative

This is a summary of the investigation into the complaint registered for receipt of a box of probechek multivysion control slides kit, 5 slides, part 30-805030 (list 05j07-001) lot 474715 that contained a broken slide.Investigation into this complaint included an evaluation of quality data review, retain sample evaluation, and complaint history review.Related manufacturing and test records were reviewed, and no errors were identified.The manufacturing process is a manual process.Slides are 100% inspected at the kit manufacturing stage for specific issues including damage.Once placed into kits, the kits are sampled and inspected by quality control.No issues were noted during inspection.In addition, a process is in place to minimize damage during shipment of slides from abbott molecular (am).A visual inspection using am retain samples from the same lot of material in question was performed to determine if products had any visually identifiable damage.No damage was identified.Aside from the complaint currently being addressed by this investigation, two additional complaints reporting broken/damaged slides were reported in the last 12 months.The current complaint rate for broken slides is (b)(4) (3 complaints for broken slides for (b)(4) units sold), indicating that the issue may be seen with a frequency of "occasional." no systemic product deficiency has been identified.

• Brand Name: PROBECHEK MULTIVYSION CONTROL SLIDES
• Type of Device: GENERAL PURPOSE REAGENT
• Manufacturer (Section D): ABBOTT MOLECULAR INC.; 1300 east touhy ave.; des plaines IL 60018 3315
• Manufacturer (Section G): ABBOTT MOLECULAR INC.; 1300 east touhy ave.; des plaines IL 60018 3315
• Manufacturer Contact: sarah parker ; 1300 east touhy ave.; des plaines, IL 60018-3315 ; 2243617355
• MDR Report Key: 6956732
• MDR Text Key: 90650333
• Report Number: 3005248192-2017-00057
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: 510(K)EXEMPT
• 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: 11/10/2017

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 Expiration Date: 01/09/2018
• Device Catalogue Number: 05J07-01
• Device Lot Number: 474715
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 10/17/2017
• Supplement Dates Manufacturer Received: 11/02/2017
• Supplement Dates FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2017
• 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