DIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL FANA200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-22 for DIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL FANA200 manufactured by Euro Diagnostica Ab.

Event Text Entries

[101136486] 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.
Patient Sequence No: 1, Text Type: N, H10


[101136487] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616003-2018-00002
MDR Report Key7288167
Date Received2018-02-22
Date of Report2018-02-20
Date of Event2015-07-21
Date Mfgr Received2015-07-21
Device Manufacturer Date2015-05-20
Date Added to Maude2018-02-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS NINA CARLQVIST
Manufacturer StreetP. O. BOX 50117 LUNDAVAGEN 151
Manufacturer CityMALMO, 20211
Manufacturer CountrySW
Manufacturer Postal20211
Manufacturer G1EURO DIAGNOSTICA AB
Manufacturer StreetP. O. BOX 50117 LUNDAVAGEN 151
Manufacturer CityMALMO, 20211
Manufacturer CountrySW
Manufacturer Postal Code20211
Single Use3
Previous Use Code3
Removal Correction Number9616003-10/09/2017-003-C
Event Type3
Type of Report0

Device Details

Brand NameDIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL
Generic NameANA
Product CodeLKJ
Date Received2018-02-22
Catalog NumberFANA200
Lot NumberSS 2009
Device Expiration Date2016-08-31
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerEURO DIAGNOSTICA AB
Manufacturer AddressP. O. BOX 50117 LUNDAVAGEN 151 MALMO, SKANE 20211 SW 20211


Patients

Patient NumberTreatmentOutcomeDate
10 2018-02-22

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