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 2017-08-24 for NUCLISENS? LYSIS BUFFER 280134 manufactured by Biom?rieux Sa.
[83652225]
A customer from (b)(6) reported to biom? Rieux they obtained colored eluates for whole blood extractions when using nuclisens? Lysis buffer (lot z018la1lb) on the emag? Platform. The customer reported that they originally saw discolored eluates in easymag? But are now observing the same issue with emag?. The majority of eluates were discolored and inhibited the downstream pcr process. The customer reported that patient results may have been affected. The customer stated there was a likelihood that wrong results were reported to a physician however due to sample storage and disposal, it is not possible to return to previously reported samples and re-test. It is not known if any patients were treated incorrectly due to wrong results. The customer stated there was a delay for reporting results, as turnaround times due to eluate discoloration are frequently greater than 24 hours. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant results led to any adverse event related to any patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00250 |
| MDR Report Key | 6816828 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-24 |
| Date of Report | 2017-09-19 |
| Date Mfgr Received | 2017-09-19 |
| Date Added to Maude | 2017-08-24 |
| 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 | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | 5, RUE DES BERGES |
| Manufacturer City | GRENOBLE CEDEX 01, FR 38024 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 38024 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLISENS? LYSIS BUFFER |
| Generic Name | NUCLISENS? LYSIS BUFFER |
| Product Code | LDT |
| Date Received | 2017-08-24 |
| Catalog Number | 280134 |
| ID Number | 03573026139346 |
| Device Expiration Date | 2017-10-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX SA |
| Manufacturer Address | 5, RUE DES BERGES GRENOBLE CEDEX 01, FR 38024 FR 38024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-24 |