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.
[101022914]
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.
Patient Sequence No: 1, Text Type: N, H10
[101022915]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616003-2018-00001 |
| MDR Report Key | 7288166 |
| Date Received | 2018-02-22 |
| Date of Report | 2018-02-20 |
| Date of Event | 2015-07-13 |
| Date Mfgr Received | 2015-07-13 |
| Device Manufacturer Date | 2015-04-27 |
| Date Added to Maude | 2018-02-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS NINA CARLQVIST |
| Manufacturer Street | P. O. BOX 50117 LUNDAVAGEN 151 |
| Manufacturer City | MALMO, 20211 |
| Manufacturer Country | SW |
| Manufacturer Postal | 20211 |
| Manufacturer G1 | EURO DIAGNOSTICA AB |
| Manufacturer Street | P. O. BOX 50117 LUNDAVAGEN 151 |
| Manufacturer City | MALMO, 20211 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 20211 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 9616003-10/09/2017-003-C |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL |
| Generic Name | ANA |
| Product Code | LKJ |
| Date Received | 2018-02-22 |
| Catalog Number | FANA200 |
| Lot Number | SS 1500 |
| Device Expiration Date | 2016-08-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EURO DIAGNOSTICA AB |
| Manufacturer Address | P. O. BOX 50117 LUNDAVAGEN 151 MALMO, SKANE 20211 SW 20211 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-22 |