MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for BILT3 BILIRUBIN TOTAL GEN.3 BIL-T G3 manufactured by Roche Diagnostics.
[134310796]
The investigation did not identify a product problem. The were no follow up/corrective actions for the event. No devices were returned. This device is not labeled for single use and is not reprocessed or reused.
Patient Sequence No: 1, Text Type: N, H10
[134310797]
This report summarizes 1 malfunction events. Erroneous low results were generated by the cobas 8000 c 702 module. The events involved a total of 1 patient with the following: one erroneous result for bilt3 bilirubin total gen. 3. The patient's age was requested, but not provided. The patient's weight was requested, but not provided. There patient's gender was requested, but not provided. The patient's race was requested, but not provided. The patient's ethnicity was requested, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-90053 |
| MDR Report Key | 8281240 |
| Date Received | 2019-01-28 |
| Date Added to Maude | 2019-01-28 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG), NA 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BILT3 BILIRUBIN TOTAL GEN.3 |
| Generic Name | DIAZO COLORIMETRY, BILIRUBIN |
| Product Code | CIG |
| Date Received | 2019-01-28 |
| Model Number | BIL-T G3 |
| Lot Number | 318161 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-28 |