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.
[86594898]
A biom? Rieux internal investigation was performed. The customer reported low results when testing the iqc "virotrol" from biorad with idas cmv igm lot 1005685430(1. 61 vt, 0. 96 vt, 1. 04 vt, 1. 11 vt and 1. 01 vt) compared to the specification the customer put in place based on results obtained on previous lots. A review of quality records confirmed there was no issue in the production of lot 1005685430. An analysis of the control chart for 5 internal samples (target : 1. 84 - 1. 27 - 2. 08 - 1. 07 - 0. 31 tv) on 9 different batches of vidas cmvm, showed that vidas cmv igm lot 1005685430/180320-0 was in the trend of the other batches. The quality product laboratory tested these 5 internal samples on the retained kit of vidas cmv igm lot 1005685430 and obtained the following results : cm34 : 1. 70 tv. Cm26 : 1. 13 tv. Cm29 : 1. 86 tv. Cm104 0. 85 tv. Cm15 : 0. 29 tv. All the results were within the specifications and similar to those obtained before the release of the batch vidas cmv igm lot 1005685430. There was no drift of lot 1005685430. The quality product laboratory had tested the iqc biorad virotrol with the vidas cmvm lot 180320-0 (retain kit) and lot 171203-0 (reference kit). The results were positive with the 2 batches. Batch 171203-0: 1. 43 tv. Batch 180320-0: 1. 04 tv. The differences observed are linked to the normal inter-lot variability which has no impact on patient result or interpretation status. The 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). The quality product laboratory recomputed the following range based on the customer's data (3 discrepant values out of 96 values not taken into account because visibly out of trend 3. 32tv, 3. 54 tv, 2. 19 tv) : mean : 1. 485 tv. 2et : [1. 164-1. 806] tv. 3et : [1. 003-1. 967] tv. According to this new statistics, customer's values excluding 3 discrepant values conform within range at 3 et (except for one value at 0,96 vt). Check with the customer how statistics are computed and suggest the customer that is also possible to work with a mobile mean. 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
[86594899]
A customer in (b)(6) notified biom? Rieux of discrepant results associated with vidas? Cmv igm (reference (b)(4)). The customer reported out of range results when testing the internal quality control virotrol from bio-rad in association with vidas? Cmv igm. The test results were: lot 180119-0 : values between 0. 72 and 1. 4 mean=0. 85 (sd=0. 15 and cv=16%)=> all the results have a positive or equivocal interpretation first (1st) calibration s1 : 1236 rfv values obtained between the 5th of june and the 12th of june : 0. 87 / 0. 79/ 0. 76 / 0. 92 / 0. 89 / 1. 4 / 0. 9 / 0. 86. Second (2nd) calibration s1 : 1376 rfv values obtained between the 13th and the 26th of june : 0. 85 / 0. 81/ 0. 78 / 0. 79/ 0. 81/0. 80 / 0. 72 /0. 74 /0. 81 /0. 79. Lot 180320-0 : values between 0. 63 and 0. 96 mean=0. 76 (sd=0. 76 and cv=17%)==> some of them are positive (0. 96), some are equivocal (0. 75 and 0. 81), 2 have a negative interpretation (0. 63 and 0. 66).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00270 |
| MDR Report Key | 6845855 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-06 |
| Date of Report | 2017-09-06 |
| Date Mfgr Received | 2017-07-12 |
| Device Manufacturer Date | 2017-05-15 |
| 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 | MS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 |
| Manufacturer Country | FR |
| 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 |
| Model Number | 30205 |
| Lot Number | 1005685430 |
| Device Expiration Date | 2018-03-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-06 |