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

Catalog Number FANA200

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 07/13/2015

Event Type  malfunction  

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 1500.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 1500 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 1500.

Event 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.A fda warning letter (cms case no.524316), 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 1500.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 1500.Nothing indicates that patient safety was compromised in the complaints.

• Brand Name: DIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL
• Type of Device: ANA
• Manufacturer (Section D): EURO DIAGNOSTICA AB; p. o. box 50117; lundavagen 151; malmo, skane 20211 ; SW 20211
• Manufacturer (Section G): EURO DIAGNOSTICA AB; p. o. box 50117; lundavagen 151; malmo, 20211 ; SW 20211
• Manufacturer Contact: nina carlqvist ; p. o. box 50117; lundavagen 151; malmo, 20211 ; SW 20211
• MDR Report Key: 7288166
• MDR Text Key: 101022914
• Report Number: 9616003-2018-00001
• Device Sequence Number: 1
• Product Code: LKJ
• UDI-Device Identifier: 07340058410486
• UDI-Public: 07340058410486
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K932876
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: FANA200
• Device Lot Number: SS 1500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2015
• Initial Date FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 9616003-10/09/2017-003-C
• Patient Sequence Number: 1