MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for COBAS B 101 HBA1C TEST manufactured by Roche Diagnostics.
[143408866]
For one of the events, the issue observed by the customer could be reproduced, but the cause can only be explained by a mishandling of the customer. A dent on the bearing plate of one cobas b 101 system was observed, causing an unstable rotation of the plate. Errors indicate that the bearing plate damage was caused by the reagent disk being set incorrectly in the analyzer. For one of the events, the investigation determined that performance testing was performed on the cobas b101 with acceptable results. The investigation did not identify a product problem. The cause of the event could not be determined. There were no follow up/corrective actions. 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
[143408867]
This report summarizes
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-90102 |
| MDR Report Key | 8551523 |
| Date Received | 2019-04-25 |
| Date Added to Maude | 2019-04-25 |
| 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 | COBAS B 101 HBA1C TEST |
| Generic Name | ASSAY, GLYCOSYLATED HEMOGLOBIN |
| Product Code | LCP |
| Date Received | 2019-04-25 |
| Model Number | B 101 HBA1C |
| Lot Number | 831041, 819041 |
| 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 | 2019-04-25 |