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 2017-09-06 for VIDAS? CMV IGM 30205 manufactured by Biomerieux, Sa.
[86583679]
The customer complained about a low result obtained when testing the iqc "virotrol" from biorad with vidas cmv igm lot 1005712890/180328-0 (tv : 1. 11) compared to the specification he had put in place based on results obtained on previous lots. The analysis of the batch history records showed no anomaly. There is no other complaint recorded for the same issue on the kit vidas cmv igm lot 1005712890/180328-0. There is no non-conformity linked to the customer's anomaly on this lot and no capa on the product reference. (b)(6). The differences observed are linked to the normal inter-lot variability which has no impact on patient result or interpretation status. Furthermore this iqc virotrol is manufactured (not natural sample) and manufacturing process can affect sample matrix, so the hypothesis is that this sample could behave differently following some lots of vidas cmvm. It is recommended that each laboratory establishes its own range for each analyte (extract from package insert virotrol torch-m). (b)(6). Check with the customer how statistics are computed and suggest the customer that is also possible to work with a mobile mean. The quality product laboratory analyzed complaints about sensitivity problem (potential false negative result) since 2013 and observed that there is no increase of complaints. Based on complaints, the relative sensitivity is about 99. 99 % and conform to package insert performances (sensitivity: 90. 24 %) according to the data mentioned above, vidas cmv igm lot 1005685430/180320-0 is within the expected specifications.
Patient Sequence No: 1, Text Type: N, H10
[86583680]
A customer in (b)(6) notified biom? Rieux of low out of range results when testing the internal quality control virotrol torch from biorad with vidas? Cmv igm lot 1005712890: (b)(6). There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. There was no patient associated with this discrepant quality control result. A biom? Rieux internal investigation was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00269 |
| MDR Report Key | 6845830 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-06 |
| Date of Report | 2018-07-16 |
| Date Mfgr Received | 2018-06-20 |
| Device Manufacturer Date | 2017-05-29 |
| Date Added to Maude | 2017-09-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX, SA |
| Manufacturer Street | 376 CHEMIN DE L'ORME |
| Manufacturer City | MARCY L'ETOILE, 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 IGM |
| Generic Name | VIDAS? CMV IGM |
| Product Code | LKQ |
| Date Received | 2017-09-06 |
| Catalog Number | 30205 |
| Lot Number | 1005712890 |
| Device Expiration Date | 2018-03-28 |
| 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, SA |
| Manufacturer Address | 376 CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-06 |