MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-12-16 for VARIANT NBS SICKLE CELL PROGRAM 250-3000 manufactured by Bio-rad Laboratories Inc..
[4309871]
The field service engineer reported a potential risk that an eluted sample disc that can adhere to the sample probe which has been seen dropped onto the microplate area may drop into an unsampled well which may cause sample contamination of the unsampled well and potentially an incorrect result.
Patient Sequence No: 1, Text Type: D, B5
[11598083]
Studies will be performed at bio-rad to measure actual impact of an eluted dropped disc into an unsampled well.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2915274-2013-00015 |
| MDR Report Key | 3724762 |
| Report Source | 07 |
| Date Received | 2013-12-16 |
| Date of Report | 2013-12-16 |
| Date of Event | 2013-11-19 |
| Date Mfgr Received | 2013-11-19 |
| Date Added to Maude | 2014-05-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SWETA OATEK |
| Manufacturer Street | 4000 ALFRED NOBEL DR. |
| Manufacturer City | HERCULES CA 94547 |
| Manufacturer Country | US |
| Manufacturer Postal | 94547 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VARIANT NBS SICKLE CELL PROGRAM |
| Generic Name | ABNOMRAL HEMOGLOBIN QUANTITATION |
| Product Code | GKA |
| Date Received | 2013-12-16 |
| Catalog Number | 250-3000 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES INC. |
| Manufacturer Address | HERCULES CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-16 |