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 2018-09-07 for IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM) 04784618190 manufactured by Roche Diagnostics.
[120255368]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[120255449]
The customer questioned results for 4 patient samples tested for elecsys cmv igg assay (cmv igg) and elecsys cmv igm immunoassay (cmv igm) on a cobas 6000 c (501) module compared to other methods. Based on the data provided, the results for 1 patient were discrepant for cmv igg and cmv igm and the results for 1 patient were discrepant for cmv igg. This medwatch will cover cmv igm. Refer to medwatch with (b)(6) for information on the cmv igg results. Refer to attached data for the patient results. The incorrect results were reported outside of the laboratory. There was no allegation that an adverse event occurred. The c501 module serial (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03030 |
| MDR Report Key | 7855714 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-07 |
| Date of Report | 2018-11-12 |
| Date of Event | 2018-05-08 |
| Date Mfgr Received | 2018-08-15 |
| Date Added to Maude | 2018-09-07 |
| 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 | IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM) |
| Generic Name | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS |
| Product Code | LFZ |
| Date Received | 2018-09-07 |
| Model Number | NA |
| Catalog Number | 04784618190 |
| Lot Number | ASKU |
| 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 | 2018-09-07 |