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 2017-10-31 for ALBUMIN GEN.2 05166861190 manufactured by Roche Diagnostics.
[91211710]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[91211711]
The customer received questionable low alb2 albumin gen. 2 results for qc material and up to 10 patient samples. The samples were repeated on another analyzer at the site. Of the data provided for two patient samples, only the results for one patient sample were discrepant. The initial result was 2. 3 g/dl and the repeat result was 2. 9 g/dl. The erroneous results were reported outside of the laboratory. The repeat results were believed to be correct and corrected reports were sent. The customer did not have any information regarding an adverse event. There was no allegation of an adverse event. The customer replaced the reagent pack and qc recovery was then in range. They repeated testing and obtained results comparable to results on other analyzer. The field service representative could not find a cause. Calibration and qc results passed. The customer used cobas 8000 c 702 module serial number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02471 |
| MDR Report Key | 6989822 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-31 |
| Date of Report | 2017-12-17 |
| Date of Event | 2017-10-14 |
| Date Mfgr Received | 2017-10-14 |
| Date Added to Maude | 2017-10-31 |
| 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 | 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 | 2017-10-31 |
| Model Number | NA |
| Catalog Number | 05166861190 |
| Lot Number | 24935901 |
| ID Number | NA |
| Device Expiration Date | 2018-07-31 |
| 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 | 2017-10-31 |