MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-10-15 for VARIANTNBS WITH GDM 3.1 SOFTWARE 250-3000 manufactured by Bio-rad Laboratories.
[3731439]
On (b)(6) 2013, a customer located in (b)(6) was using the variant nbs sickle cell program and noticed that a sample ((b)(6)) appeared twice on the summary report. Within the same run, a sample result ((b)(6)) showed a flat line with no peaks on the chromatogram. On (b)(6) 2013, the operator repeated the entire run to further investigate the results that appeared twice on the summary report as well as the flat line chromatogram. The summary report from the second run contained no repeated samples and all chromatograms showed peaks (no flat lines). The incident was reported to bio-rad labs.
Patient Sequence No: 1, Text Type: D, B5
[11375491]
For preliminary investigation bio-rad obtained: back up from the investigation's database, punch file, summary and chormatograms of initial run and repeat run.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2915274-2013-00010 |
| MDR Report Key | 3458984 |
| Report Source | 01,07 |
| Date Received | 2013-10-15 |
| Date of Report | 2013-10-15 |
| Date of Event | 2013-09-13 |
| Date Mfgr Received | 2013-09-17 |
| Date Added to Maude | 2014-01-27 |
| 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 PATEL |
| Manufacturer Street | 4000 ALFRED NOBEL DR. |
| Manufacturer City | HERCULES CA 94547 |
| Manufacturer Country | US |
| Manufacturer Postal | 94547 |
| Manufacturer Phone | 5107415157 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VARIANTNBS WITH GDM 3.1 SOFTWARE |
| Generic Name | ABNORMAL HEMOGLOBIN QUANTITATION |
| Product Code | GKA |
| Date Received | 2013-10-15 |
| 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 |
| Manufacturer Address | 4000 ALFRED NOBEL DR. HERCULES CA 94547 US 94547 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-15 |