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 2018-02-23 for NUCLISENS? EASYMAG? DISPOSABLE 280135 manufactured by Biomerieux Sa.
[101138657]
A biom? Rieux internal investigation was performed. A vessel was visually inspected, and a plastic split on the first well of the vessel was observed. The investigation with the supplier determined there was an issue either during inspection of the pieces or during transportation of packaged disposables. As a corrective action, the supplier will update the packing handling symbols on the outer boxes of the nuclisens? Easymag? Disposable in order to implement a careful handling of the products during shipment. In addition, the supplier will dispense a specific training to the teams working at each step of the nuclisens? Easymag? Disposable manufacturing. The goal will be to clarify the nonconforming products detection and the appropriate actions to implement during manufacturing.
Patient Sequence No: 1, Text Type: N, H10
[101138659]
A customer in (b)(6) reported a leakage problem with the nuclisens? Easymag? Disposable (lot z108kc). The customer reported receiving error codes for three disposable vessels, while performing whole blood extractions. The customer stated there was an error on the first vessel and during analysis of the second vessel. The customer stated the first vessel was rejected and the extractions were then obtained using wf5. The pcr results were reported as meeting expectations. Later, the customer reported that position one (negative control) leaked from another vessel. The customer indicated that all the issues started in the beginning of the week with the lot. There is no indication from the laboratory that the issue led to discrepant results or adverse events related to the patient, nor any report that the leaking vessel led to any adverse events related to the user; however, there was unexpected leakage of sample/reagent contents.
Patient Sequence No: 1, Text Type: D, B5
[121929689]
Correction: manufacturing site corrected. Narrative from previous submission: a biom? Rieux internal investigation was performed. A vessel was visually inspected and a plastic split on the first well of the vessel was observed. The investigation with the supplier, determined there was an issue either during inspection of the pieces or during transportation of packaged disposables. As a corrective action, the supplier will update the packing handling symbols on the outer boxes of the nuclisens? Easymag? Disposable in order to implement a careful handling of the products during shipment. In addition, the supplier will dispense a specific training to the teams working at each step of the nuclisens? Easymag? Disposable manufacturing. The goal will be to clarify the nonconforming products detection and the appropriate actions to implement during manufacturing.
Patient Sequence No: 1, Text Type: N, H10
[121929690]
A customer in (b)(6) reported a leakage problem with the nuclisens? Easymag? Disposable (lot z108kc). The customer reported receiving error codes for three disposable vessels, while performing whole blood extractions. The customer stated there was an error on the first vessel and during analysis of the second vessel. The customer stated the first vessel was rejected and the extractions were then obtained using wf5. The pcr results were reported as meeting expectations. Later, the customer reported that position one (negative control) leaked from another vessel. The customer indicated that all the issues started in the beginning of the week with the lot. There is no indication from the laboratory that the issue led to discrepant results or adverse events related to the patient, nor any report that the leaking vessel led to any adverse events related to the user; however, there was unexpected leakage of sample/reagent contents.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00021 |
| MDR Report Key | 7292889 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-23 |
| Date of Report | 2018-02-23 |
| Date Mfgr Received | 2017-08-24 |
| Device Manufacturer Date | 2007-05-07 |
| Date Added to Maude | 2018-02-23 |
| 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 | 5, RUE DES BERGES |
| Manufacturer City | GRENOBLE CEDEX 01, MO 38024 |
| Manufacturer Country | FR |
| Manufacturer Postal | 38024 |
| 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 | NUCLISENS? EASYMAG? DISPOSABLE |
| Generic Name | NUCLISENS? EASYMAG? DISPOSABLE |
| Product Code | JJH |
| Date Received | 2018-02-23 |
| Catalog Number | 280135 |
| Lot Number | Z108KC |
| Device Expiration Date | 2018-09-28 |
| 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 | 5, RUE DES BERGES 2181 AB HILLEGOM GRENOBLE CEDEX 01, 38024 FR 38024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-23 |