MAUDE Adverse Event Report: EURO DIAGNOSTICA AB DIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL; ANA

Catalog Number	FANA200
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/21/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation concluded, after testing retain material at euro diagnostica, that although product quality requirements stated in the instructions for use were met at lot release, the high background in the elisa plate, the strong igm conjugate, and the low reference control led to an increased risk of equivocal sample test results for fana200 kit lot ss 2009.This may not cause a safety risk to patients, but is a product malfunction.The instructions for use clearly states that a positive result in fana200 should be verified in a more specific assay.However, there is a remote risk that treatment may be started up based on a false positive result, which could be critical for patient health and safety.No kits of fana200 lot ss 2009 is currently on the market due to a completed recall and the expired shelf-life of the lot.There is deemed to currently be no patient safety risk regarding fana200 lot ss 2009.
Event or Problem Description
During fda audit of our company, the auditor assessed complaints (b)(4), and deemed the actions in the complaints to fall under 21cfr§806 reports of corrections and removals.An fda warning letter (cms case no.(b)(4)), issued september 20th, 2017, to our company pointed to the requirement to file a report of corrections and removals retrospectively for the two complaint lots.The reporting of corrections and removals for complaints (b)(4) was performed in sept.2017, retrospectively (9616003-10/09/2017-003-c).One more complaint, (b)(4), was identified in jan.2018, for the same product lots during a review of complaints from 2015-2016 to assess the complaints for mdr and/or recall reportability.An mdr was not filed at the time of the reporting of correction and removals of the complaints.The company has since then reassessed the complaints, and is now filing mdrs regarding the two complaint lots fana200 ss 1500 and fana200 ss 2009, in the three complaints ((b)(4)).This mdr is regarding fana200 ss 2009.Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the elisa plate, the strong igm conjugate, and the low reference control led to an increased risk of equivocal sample test results for fana200 kit lot ss 2009.Nothing indicates that patient safety was compromised in the complaints.

• Brand Name: DIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL
• Common Device Name: ANA
• Manufacturer (Section D): EURO DIAGNOSTICA AB; p. o. box 50117; lundavagen 151; malmo, skane 20211 ; SW 20211
• MDR Report Key: 7288167
• Report Number: 9616003-2018-00002
• Device Sequence Number: 957811
• Product Code: LKJ
• UDI-Device Identifier: 07340058410486
• UDI-Public: 07340058410486
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K932876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/20/2018

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: 08/31/2016
• Device Catalogue Number: FANA200
• Device Lot Number: SS 2009
• 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: 07/21/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 9616003-10/09/2017-003-C
• Patient Sequence Number: 1