MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-10-17 for ELECSYS CMV IGG ASSAY 07027117190 manufactured by Roche Diagnostics.
[126096679]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[126096680]
The customer stated that they received questionable results for four patient samples tested with the elecsys (b)(6) assay on a cobas 8000 e 602 module. Of the four samples, three had erroneous (b)(6) results. The erroneous results were not reported outside of the laboratory. The roche (b)(6) values were compared to measurements performed with the abbott architect assay. The cutoff value used for the abbott assay was asked for, but not provided. No units of measure were provided for the abbott assay. The first sample resulted with a (b)(6) value of (b)(6). The sample was tested with the abbott assay, resulting as (b)(6). The second sample resulted with a (b)(6) value of (b)(6). The sample was tested with the abbott assay, resulting as (b)(6). The third sample resulted with a (b)(6) value of (b)(6). The sample was tested with the abbott assay, resulting as (b)(6). No adverse events were alleged to have occurred with the patients. The serial number of the e 602 analyzer is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03718 |
| MDR Report Key | 7973779 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-17 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-08-14 |
| Date Mfgr Received | 2018-09-26 |
| Date Added to Maude | 2018-10-17 |
| 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 | 3 |
| Brand Name | ELECSYS CMV IGG ASSAY |
| Generic Name | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS |
| Product Code | LFZ |
| Date Received | 2018-10-17 |
| Model Number | NA |
| Catalog Number | 07027117190 |
| Lot Number | 252341 |
| 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 | 2018-10-17 |