MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-12-08 for VIDAS? LYME IGG 30320 manufactured by Biomerieux, S.a..
[61851383]
A customer in poland notified biom? Rieux of false negative results associated with vidas? Lyme igg assay (reference (b)(4)) related to a patient sample. The customer reported the male patient was bitten by a tick in (b)(6) 2015. Erythema migraines were observed, but not characteristic. The patient was not treated. The patient was tested using vidas? Lyme igg on (b)(6) 2015 and the result was negative (0. 03). The patient had neurological symptoms but was not treated for borreliosis, because of the negative test result. Due to worsening symptoms the patient was tested again (b)(6) 2016 on vidas? Lyme igg and the result was negative. To confirm the result, the customer performed wb test and received a positive result on wb igg. At preset, the patient is in the hospital of infectious diseases with symptoms of advanced late neuroborreliosis. The customer reported a concern about the discrepancy of the results between vidas? Lyme igg and we and checked another positive sample on both assays. The result on vidas? Lyme igg was negative and positive on wb. Samples are frozen and available for investigation. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[70465814]
Biom? Rieux conducted an internal investigation: the analysis of the batch history record vidas lyme igg lot 1005029860 /170708-0 showed no anomaly during the control linked to the customer's issue. The quality product laboratory tested five (5) samples on the retain kit lot 170708-0 and lot 171116-0 (another batch with different raw materials): target: vt : 0. 73vt,1. 58 vt,0. 82 vt,0. 6 vt and 0. 02 vt. The analysis of control card showed that the vidas lyme igg lot 1005029860 /170708-0 was in the trend of the other observed batches. All the samples results were within the expected specifications on the 2 tested batches (lots 170708-0, and 171116-0). The quality product laboratory did not observed any evolution of vidas lyme igg lot 1005029860 /170708-0 since it release on july 27th 2016. The both return sample (ap and wn) were tested on vidas lym igg lot 170708-0 (customer batch) and lot 171116-0 (another batch with different raw materials) and vidas lym igm lot 170208-0. Vidas lym igg lot 170708-0: wn : 0. 04 vt: negatif, ap : 0. 02 vt: negatif. Vidas lym igg lot 171116-0: wn : 0. 05 vt: negatif, ap: 0. 02 vt: negatif. Vidas lym igm lot 170208-0: wn : 0. 01 vt: negatif, ap: 0. 06 vt: negatif. All the results are confirmed negative. The quality product laboratory had tested both the return sample (ap and wn) with biosynex (western blot technique). The results were found negative in lyme igg. Moreover the sample ap were tested with diasorin lia lyme igm and igg , in lyme igg: ap results: <5 ua/ml: negative result ; range :>14 ua/ml positives results in lyme igm: ap results:12 ua/ml: negative result; range:>21 ua/ml positive results. The results were found negative on lyme ig and igm. The second sample wn can't be tested for a lack of volume. The results obtained in diasorin lyme igg and in biosynex igg are in accordance with vidas method. Diasorin (other eia technique) confirms the negative result obtained with vidas lyme igg. Biosynex confirms only p41 band, no other band are present, the result of the western blot is negative as vidas lyme igg results. The performance of vidas lyme igg lot 1005029860 /170708-0 are within expected specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00505 |
| MDR Report Key | 6155090 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-08 |
| Date of Report | 2017-03-20 |
| Date Mfgr Received | 2017-02-21 |
| Date Added to Maude | 2016-12-08 |
| 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 | ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS? LYME IGG |
| Generic Name | VIDAS? LYME IGG |
| Product Code | LSR |
| Date Received | 2016-12-08 |
| Catalog Number | 30320 |
| Lot Number | 1005029860 |
| Device Expiration Date | 2017-07-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, S.A. |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-08 |