MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-06 for DIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL FANA200 manufactured by Euro Diagnostica Ab.
[69373268]
The customer, (b)(6), stated that multiple samples resulting positive by the ana screen (fana200, lot ts 2076) result negative during the secondary autoantibody specificity testing. The customer stated that both levels of controls resulted within manufacturer range. The customer stated that no ana results were reported out from customer. No device has been returned to euro diagnostica. Testing of retain material at euro diagnostica with a sample panel form healthy donors showed that there was an increased risk for equivocal sample results with the fana200 lot ts 2076. Investigation suggests that the plate coating results in high background, and the igg conjugate is unstable over time. The shelf-life of the product cannot be guaranteed. There is a risk that users get false positive test results. This may not cause a safety risk to patients, but is a product malfunction. However based on product information to customers, there is a risk that treatment may be started up based on a false positive result, which could be critical for patient health and safety. Based on data from complaint investigation, the quality review board decision is that fana200 lot ts2076 is recalled to avoid risk to patient health and safety. The recall decision was made feb. 14. All affected countries regulatory authorities, as well as all affected euro diagnostica customers, have been notified of the recall. Other fana lots in house, not yet released to market, have been quarantined awaiting further investigation. A field safety notice was sent out, and customers were advised to re-test all positive sample results if treatment was initiated based on results from ana ts 2076. The extent of the problem is presently deemed to be only fana200 ts 2076. Investigation is still on-going to determine if other euro diagnostica products are affected. Access to the production emdr account was given until friday evening, march 3. Hence, the mdr could not be filed until now.
Patient Sequence No: 1, Text Type: N, H10
[69373269]
The customer, (b)(6), stated that multiple samples resulting positive by the ana screen (fana200, lot ts 2076) result negative during the secondary autoantibody specificity testing. The customer stated that both levels of controls resulted within manufacturer range. The customer stated that no ana results were reported out from customer. Testing of retain material at euro diagnostica with a sample panel form healthy donors showed that there was an increased risk for equivocal sample results with the fana200 lot ts 2076.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616003-2017-00001 |
| MDR Report Key | 6379820 |
| Date Received | 2017-03-06 |
| Date of Report | 2017-03-06 |
| Date of Event | 2017-01-30 |
| Date Mfgr Received | 2017-02-02 |
| Device Manufacturer Date | 2016-07-20 |
| Date Added to Maude | 2017-03-06 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 |
| Manufacturer City | MALMO, SKANE 20211 |
| Manufacturer Country | SW |
| Manufacturer Postal | 20211 |
| Manufacturer Phone | 640537632 |
| Manufacturer G1 | EURO DIAGNOSTICA AB |
| Manufacturer Street | P. O. BOX 50117 |
| Manufacturer City | MALMO, SKANE 20211 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 20211 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL |
| Generic Name | ANA |
| Product Code | LKJ |
| Date Received | 2017-03-06 |
| Catalog Number | FANA200 |
| Lot Number | TS 2076 |
| Device Expiration Date | 2017-08-21 |
| Operator | BIOMEDICAL ENGINEER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EURO DIAGNOSTICA AB |
| Manufacturer Address | P. O. BOX 50117 MALMO, SKANE 20211 SW 20211 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-06 |