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 2016-01-21 for VIDAS? CMV IGG 30204 manufactured by Biomerieux Sa.
[36479957]
A customer in (b)(6) reported receiving a 522 error during liquid transfer while using the; vidas? Cmv igg.
Patient Sequence No: 1, Text Type: D, B5
[48203073]
A customer in (b)(6) reported receiving a blocking error "0522" during vidas? Cmv igg (reference (b)(4)/lot 1004289340) assay. An internal biom? Rieux investigation was conducted with the following results: in the case of a 522 error, the following message is displayed on vidas? 3: "air detected when an aspiration is performed during the analytical protocol. " as a consequence, the calibration or test is invalidated. The user is blocked until the test is repeated without error. The error occurs while section? Smart pump? (ref. (b)(4)) is aspirating sample from the strip. Both assays (toxo igg and cmv igg) share the same protocol and are susceptible to react in the same manner (variability of pressure recorded) in case of variability in the spr production. Symptoms include: 0522 error/flag 0 occurring with some spr bags. Impact on biological result: users are blocked until they repeat the test and get results without error; however, according to customer logs and tests performed, the signal (rfv value) is not impacted by the 0522 error. The biological results are not impacted and the 0522 error reported by the vidas? 3 is considered a false alarm in this case. The issue has been observed as an effect from batch manufacturing related to the spr itself. This creates a variability of pressure interpreted as error 0522 by the instrument. This phenomenon happens only with assays working with protocols where sample aspiration involves low volume and high speed. Assays using other protocols are not impacted. Pressure interpretation was designed to detect problems during aspiration (bubbles, leaks, pumps blocked), it is now disturbed by this phenomenon. This issue is being managed under a capa to identify root cause and provide corrective/preventative actions. Immediate action/workaround to avoid the false alarm is to rerun the calibration or test with a different spr from the second bag within the same kit or an spr from a new kit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00017 |
| MDR Report Key | 5382466 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-01-21 |
| Date of Report | 2016-01-08 |
| Date Mfgr Received | 2016-01-08 |
| Device Manufacturer Date | 2015-09-22 |
| Date Added to Maude | 2016-01-21 |
| 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 | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS? CMV IGG |
| Generic Name | VIDAS? CMV IGG |
| Product Code | LFZ |
| Date Received | 2016-01-21 |
| Catalog Number | 30204 |
| Lot Number | 1004289340 |
| Device Expiration Date | 2016-07-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-21 |