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 2017-10-10 for ELECSYS CMV IGG ASSAY 07027117190 manufactured by Roche Diagnostics.
[90165636]
This event occurred in (b)(6). (b)(4) - (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90165637]
The customer complained of a false negative result for 1 patient sample tested for elecsys cmv igg assay (cmv igg) on a cobas e 801 module. The false negative result was not reported outside of the laboratory. Refer to the attached data for the patient results from the e801 module. The sample from (b)(6) 2017 was repeated by the vidas method and an elisa method and the cmv igg results and cmv igm results were positive. The actual results were not provided. The cmv igg avidity result from the vidas method was (b)(4). The patient had been pregnant and gave birth to a child on (b)(6). There was no allegation that an adverse event occurred. The e 801 module serial number was not provided. The sample from (b)(6) 2017 is no longer available for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02242 |
| MDR Report Key | 6935192 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-10 |
| Date of Report | 2017-11-15 |
| Date of Event | 2017-07-11 |
| Date Mfgr Received | 2017-09-21 |
| Date Added to Maude | 2017-10-10 |
| 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 | ELECSYS CMV IGG ASSAY |
| Generic Name | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS |
| Product Code | LFZ |
| Date Received | 2017-10-10 |
| Model Number | NA |
| Catalog Number | 07027117190 |
| Lot Number | 170453 |
| 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 | 2017-10-10 |