MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-07-14 for IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM) 04784618190 manufactured by Roche Diagnostics.
[49636833]
(b)(6). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[49636834]
The sales representative indicated that the customer complained of erroneous results for 1 pregnant patient tested for igm antibodies to cytomegalovirus (cmv igm) and igg antibodies to cytomegalovirus (cmv igg). The date of event was not known. The erroneous results were reported outside of the laboratory. This medwatch will cover cmv igm. Refer to medwatch with (b)(6) for information on the cmv igg erroneous results. The initial cmv igm and cmv igg results from the e602 analyzer were negative. The actual results were not provided. The physician did not believe these results. The sample was sent to an external laboratory using the abbott method and the cmv igm and cmv igg results were positive. The actual results were not provided. No adverse event occurred. The e602 analyzer serial number was (b)(4). The customer provided additional cmv igm and igg results from (b)(6) 2016. The customer believes that these results show that seroconversion was not detectable on the e602 analyzer.
Patient Sequence No: 1, Text Type: D, B5
[55165755]
A specific root cause could not be identified. Additional information was requested for investigation but was not provided. The customer submitted a sample from 06/14/2016 and the discrepant results were from a sample from 06/23/2016. The sample from 06/23/2016 was not available for investigation. The sample from 06/14/2016 was tested. The sample produced positive results for the elecsys cmv igm assay, the recomline cmv igm assay, the elecsys cmv igg assay and the recomline cmv igg assay. The elecsys cmv igg avidity results were low. The data indicate the patient had been recently infected with cmv. The sample from 06/14/2016 produced results that were comparable to the competitor system
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00924 |
| MDR Report Key | 5794810 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-07-14 |
| Date of Report | 2016-09-12 |
| Date of Event | 2016-06-23 |
| Date Mfgr Received | 2016-06-23 |
| Date Added to Maude | 2016-07-14 |
| 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 | 2016-07-14 |
| Model Number | NA |
| Catalog Number | 04784618190 |
| Lot Number | ASKU |
| 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 | 2016-07-14 |