MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-04 for ALBP ALBUMIN BCP ALB BCP 05975573190 manufactured by Roche Diagnostics.
[141107763]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[141107764]
The initial reporter complained of discrepant results for 3 patient samples tested for albp albumin bcp (albp) on a cobas 8000 c 702 module. Patient 1 initial albp result was 68 g/l. The repeat result was 43 g/l. Patient 2 initial albp result was 58 g/l. The repeat result was 40 g/l. Patient 3 initial albp result was 81 g/l. The repeat result was 43 g/l. No erroneous results were reported outside of the laboratory. There was no allegation that an adverse event occurred. The c702 module serial number was (b)(4). The field service engineer (fse) visited the customer site and adjusted the sample probe and rinse unit. One of the sample probes was replaced by the customer. The customer has not provided any additional information for investigation. The investigation did not identify a product problem. The cause of the event could not be determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01365 |
| MDR Report Key | 8483242 |
| Date Received | 2019-04-04 |
| Date of Report | 2019-04-04 |
| Date of Event | 2018-10-04 |
| Date Mfgr Received | 2019-03-12 |
| Date Added to Maude | 2019-04-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA 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 | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALBP ALBUMIN BCP |
| Generic Name | BROMCRESOL PURPLE DYE-BINDING, ALBUMIN |
| Product Code | CJW |
| Date Received | 2019-04-04 |
| Model Number | ALB BCP |
| Catalog Number | 05975573190 |
| Lot Number | 35651401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-04 |