MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-02-01 for ALBUMIN GEN.2 05166861190 manufactured by Roche Diagnostics.
[99004491]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[99004492]
The customer received questionable alb2 albumin gen. 2 results for multiple patient samples from cobas 8000 c 702 module serial number (b)(4). The customer performs qc every four hours and if the results are out of range, they repeat patient samples. Of the data provided, only the results for one sample were discrepant. The initial result was 1. 9 g/l and the repeat result was 2. 5 g/l. The erroneous result was reported outside of the laboratory. The repeat result was believed to be correct. The patient was not adversely affected. The customer believed the issue occurred when the reagent pack volume was low. After evaluation of the provided calibration and qc data, a general reagent issue cannot be identified.
Patient Sequence No: 1, Text Type: D, B5
[132936175]
The field service representative checked the instrument and found no issues. The investigation was unable to find a definitive root cause. A general reagent or hardware issue was excluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2018-00290 |
| MDR Report Key | 7233467 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-02-01 |
| Date of Report | 2018-02-20 |
| Date of Event | 2018-01-10 |
| Date Mfgr Received | 2018-01-15 |
| Date Added to Maude | 2018-02-01 |
| 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 | 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 | 3 |
| Brand Name | ALBUMIN GEN.2 |
| Generic Name | BROMCRESOL GREEN DYE-BINDING, ALBUMIN |
| Product Code | CIX |
| Date Received | 2018-02-01 |
| Model Number | NA |
| Catalog Number | 05166861190 |
| Lot Number | 262685 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2018-02-01 |