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 2016-08-19 for VIDAS? D DIMER EXCLUSION II 30455 manufactured by Biomerieux Sa.
[52722604]
A customer in (b)(6) notified biomerieux of a false negative result of <45 ng/ml associated with vidas d dimer exclusion ii (reference (b)(4)) involving a human plasma sample. The customer indicated the test was repeated and the result was 919. 42 ng/ml. The customer reported there was no harm to the patient or erroneous treatment; however, the incorrect result was reported to a physician. The physician requested a repeat test be performed. The customer indicated there was no delay in obtaining results. An internal biomerieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[58725435]
An investigation into a false negative result event while using the vidas? D dimer exclusion ii test kit was performed. The customer obtained a negative result with the vidas? Lyme igg test kit. Testing at a reference lab by western blot provided a positive result. The patient sample was not returned for investigational testing; therefore, this complaint could not be confirmed. Nine quality control samples near the cutoff value were run on retain samples from the lot involved within this complaint. All results were within expected values. A review of the batch production record and original quality control release testing was performed. No related anomalies or abnormalities were found. Based on the results of the investigation, the complaint could not be confirmed and the product is operating within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00150 |
| MDR Report Key | 5888407 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-19 |
| Date of Report | 2016-07-22 |
| Date Mfgr Received | 2016-07-22 |
| Device Manufacturer Date | 2015-10-20 |
| Date Added to Maude | 2016-08-19 |
| 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 | 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 | 2016-08-19 |
| Catalog Number | 30455 |
| Lot Number | 1004366880 |
| Device Expiration Date | 2016-09-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-08-19 |