MAUDE Adverse Event Report: EURO DIAGNOSTICA AB IMMUNOSCAN CCPLUS

Catalog Number	RA-96 PLUS
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon contact with (b)(4), the agency informed euro diagnostica that the immunoscan ccplus kits were purchased, in total (b)(4) kits over the last 3-4 months, from (b)(4).The kits were only supplied to (b)(6).(b)(4) said that neither (b)(6) nor (b)(4) had any stock left of these immunoscan ccplus kits from (b)(4)\.To the best of our knowledge, this is the only euro diagnostica product counterfeit.
Event or Problem Description
During a retrospective review, performed in jan 2018, of complaints filed by euro diagnostica in 2015-2016 to assess the complaints for mdr and/or recall reportability, one complaint (b)(4) was identified as requiring remediation.A mdr is therefore submitted to the fda retrospectively for the complaint.It came to euro diagnostica's attention on (b)(4) 2016, from (b)(4), an (b)(4) distributor, that an euro diagnostica product end-user, (b)(6), obtained immunoscan ccplus kits with falsified labeling.On (b)(4) 2016, euro diagnostica's qa dept.Was informed of the matter, and could confirm that the labels were not genuine euro diagnostica labels.On the kit box, two labels had been placed: - one label, placed on the short side of the kit box, stated euro diagnostica as the manufacturer and (b)(4) as importer, with kit manufacturing date (mfd) 2015-04-16.- the other label, placed on the long side of the kit box, was very similar to euro diagnostica's kit box label for immunoscan ccplus with a genuine immunoscan ccplus kit lot (ss 1337) and the correct expiry date (2016-08-18) for that lot.The false label could be recognized on several items, e.G.Lacking symbols, wrong symbols and having the spelling mistake of (b)(4) as "(b)(4)" in the bottom left corner.On genuine euro diagnostica immunoscan ccplus kit boxes, only one label is present on the kit box long side.(b)(4) is a former euro diagnostica distributor from (b)(4).Euro diagnsotica's last immunoscan ccplus shipment to (b)(4) was on lot rs 2432 (exp.Date 2015-12-10), on (b)(6) 2014.The immunoscan ccplus kit lot ss 1337 was never sold by euro diagnostica to (b)(4).Euro diagnostica received information that the end-user obtained the immunoscan ccplus kits from a subdealer, (b)(4).Upon contact, (b)(4) informed euro diagnostica that the kits were purchased, in total 3-4 kits over the last 3-4 months, from (b)(4).The kits were only supplied to (b)(6).(b)(4) said that neither (b)(6) nor (b)(4) had any stock left of these immunoscan ccplus kits from (b)(4).(b)(4) will, when going forward, purchase the product from euro diagnostica's distributor, (b)(4).Euro diagnostica contacted (b)(6) to inform them that no immunoscan ccplus kits from (b)(4) were to be used in patient diagnosis.The kit box was never returned to euro diagnostica.Nor were pictures obtained of the kit content.It could therefore not be determined if the kit was an expired euro diagnostica kit with new, falsified, labels on it, or if the kit components were falsified as well.Our assessment is that, most likely, the kit is from an expired immunoscan ccplus kit lot which was relabeled and sold by (b)(4).(b)(4)'s managing director denies any wrongdoing.Formal letters have been sent to (b)(4) and the (b)(4) health authority (b)(4).No reply was obtained from either party.Using expired immunoscan ccplus could lead to an increased risk of obtaining false negative test results.

• Brand Name: IMMUNOSCAN CCPLUS
• Common Device Name: CCPLUS
• Manufacturer (Section D): EURO DIAGNOSTICA AB; p. o. box 50117; lundavagen 151; malmo, 20211 ; SW 20211
• MDR Report Key: 7288168
• Report Number: 9616003-2018-00003
• Device Sequence Number: 1212439
• Product Code: NHX
• UDI-Device Identifier: 07340058410868
• UDI-Public: 07340058410868
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K091657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 02/21/2018

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
• Operator of Device: Other
• Device Expiration Date: 08/18/2016
• Device Catalogue Number: RA-96 PLUS
• Device Lot Number: SS 1337
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2016
• Initial Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1