MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-29 for ALBUMIN BCG METHOD 11929640216 manufactured by Roche Diagnostics.
[17411100]
The user received questionable albumin results from the analytical d module analyzer serial number (b)(4) that were discovered when they were compared to the patient's previous results. The user stated they had to correct results for about 20 patient samples. However, specific data was provided for only one patient sample. The initial result was 2. 1 g/dl and was reported outside the laboratory. The repeat result was 3. 5 g/dl. The patients were not adversely affected. The albumin r2 reagent lot number was 63700201. Upon evaluation of the analyzer, the field service representative found a partially clotted sample probe and styletted all four sample probes. To verify the analyzer operation, he performed precision checks with all results within specifications.
Patient Sequence No: 1, Text Type: D, B5
[17653033]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-03505 |
| MDR Report Key | 2143296 |
| Report Source | 05,06 |
| Date Received | 2011-06-29 |
| Date of Report | 2011-06-28 |
| Date of Event | 2011-06-16 |
| Date Mfgr Received | 2011-06-16 |
| Date Added to Maude | 2011-06-29 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| 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 BCG METHOD |
| Generic Name | BROMCRESOL GREEN DYE-BINDING, ALBUMIN |
| Product Code | CIX |
| Date Received | 2011-06-29 |
| Model Number | NA |
| Catalog Number | 11929640216 |
| Lot Number | 63632101 |
| ID Number | NA |
| Device Expiration Date | 2012-02-29 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-29 |