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 2016-12-30 for VIDAS? D DIMER EXCLUSION II 30455 manufactured by Biomerieux Sa.
[63654037]
A customer in (b)(6) notified biom? Rieux of falsely under-estimated result associated with vidas? D dimer exclusion ii (reference 30455). The customer indicated the test was repeated multiple times with results 1254. 70 and 1421. 45ng/ml. The customer reported there was no harm to the patient or erroneous treatment; however, the incorrect result was not reported to the physician. The customer indicated there was a two (2) hour delay in obtaining results. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[73489543]
A customer in (b)(4) notified biom? Rieux of falsely under-estimated result associated with vidas? D dimer exclusion ii. An internal biom? Rieux investigation was performed. Vidas? D-dimer results not conform to the clinical status of the patient were found in positions d1 and e1. These results could be explained by a customer manipulation error, a reagent issue or an instrument issue. - a new d-dimer result, obtained the same day in e1 position of the instrument, was conform to the clinical status of the same patient. This result shows that the probability to have an instrument issue in e1 position is very low as nothing has been done on the system between each test. - qcv test results performed by the customer on (b)(6) 2016 and then by field service engineer (fse) on (b)(6) 2016 were conform in all positions of the instrument. - leak test results performed during the preventive maintenance by the fse in (b)(6) 2016 were conform in all positions of the instrument these results show that the probability to have an instrument issue in d1 and e1 positions is very low. Investigation at reagent level: - the customer's issue was not reproduced on the biom? Rieux pv kit and the customer return kit vidas dex ii lot 1005070940 / 170729-0 using an internal sample with a similar concentration. Unfortunately, the customer's sample was not available. - the kit vidas dex ii lot 1005070940 / 170729-0 is still in the current performance expectations. In conclusion, investigation did not reveal an instrument issue or a reagent issue in d1 and e1 positions. Main probable root cause could be a customer manipulation error during pre-analytics steps (missing sample, missing spr, inadequate spr or strip not correctly inserted). The customer indicated that after the fse intervention on (b)(6) 2016, they no longer obtained unexpected results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00537 |
| MDR Report Key | 6215921 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-30 |
| Date of Report | 2017-04-20 |
| Date Mfgr Received | 2017-03-24 |
| Date Added to Maude | 2016-12-30 |
| 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 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? D DIMER EXCLUSION II |
| Generic Name | VIDAS? D DIMER EXCLUSION II |
| Product Code | DAP |
| Date Received | 2016-12-30 |
| Catalog Number | 30455 |
| Lot Number | 1005070940 |
| Device Expiration Date | 2017-07-29 |
| 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 | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-30 |