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 2017-12-06 for IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM) 04784618190 manufactured by Roche Diagnostics.
[95010753]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[95010755]
The customer received a (b)(6) elecsys cmv igm immunoassay result for one patient sample. The result from a cobas 6000 e 601 module was (b)(6). No specific result was provided. The result was reported to the patient's physician, but as it was discrepant from the previous result for the patient the sample was repeated. The sample was repeated and the result from vidas, liason xl, and another unknown analyzer were all (b)(6). No specific results were provided. There was no allegation of an adverse event. The patient's diagnosis was not affected. The analyzer serial number was requested but was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02851 |
| MDR Report Key | 7086080 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-06 |
| Date of Report | 2018-02-19 |
| Date of Event | 2017-11-15 |
| Date Mfgr Received | 2017-11-21 |
| Date Added to Maude | 2017-12-06 |
| 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 | IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM) |
| Generic Name | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS |
| Product Code | LFZ |
| Date Received | 2017-12-06 |
| Model Number | NA |
| Catalog Number | 04784618190 |
| Lot Number | 176724 |
| 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 | 2017-12-06 |