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 2016-10-04 for IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM) 04784618190 manufactured by Roche Diagnostics.
[56369708]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[56369709]
The customer complained of (b)(6) results for 1 patient tested for (b)(6). The (b)(6) results were reported outside of the laboratory. The initial patient sample was drawn on (b)(6) 2016 and the result on (b)(6) 2016 from the e602 instrument was (b)(6) ((b)(6)). An additional sample was drawn on (b)(6) 2016 and the result on (b)(6) 2016 was (b)(6) ((b)(6)) on the e602 instrument. A repeat result by the vidas method on (b)(6) 2016 was (b)(6) ((b)(6)). A different sample was also tested on (b)(6) 2016 by the vidas method and the result was (b)(6) ((b)(6)). It is not clear which vidas result was from the (b)(6) 2016 sample and which result was from the (b)(6) 2016 sample. This information was requested but not provided. The results from an additional method were also (b)(6). The actual results were not provided. The patient's clinician recommended that she discontinue her (b)(6) weeks. It is not known why this decision was made. This information has been requested, but could not be provided. There is no report that this decision was made based on the (b)(6) results from the roche product. The e602 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[58380122]
The patient sample was submitted for investigation. The sample was tested with the elecsys cmv igm immunoassay, the elecsys cmv igg immunoassay and the elecsys cmv igg avidity test on a cobas e601 analyzer used at the investigation site. The sample was also tested with the cmv recomline assay from (b)(4). The sample was negative when tested with the elecsys cmv igm assay and positive when tested with the elecsys cmv igg assay. The elecsys cmv igg avidity test detected cmv specific igg antibodies with high avidity. The cmv specific igg antibodies were of high avidity as shown by the investigation results and the vidas results provided by the customer. The customer's results could be confirmed. The negative roche cmv igm results were comparable to a recomline blot result that was negative. The elecsys cmv igm result is assumed to be correctly negative. The results from the investigation point to a late phase cmv infection. A high avidity during the first 12-16 weeks of pregnancy can be considered a good indicator of a past infection. The detection of igm antibodies can show considerable variability depending on the assay used and the individual patient. Certain assays detect persisting igms more frequently than others. The additional assessment of the associated igg and igg avidity status is recommended for determining the stage of infection. Also, guidelines provided by healthcare providers can further advise on how to follow up on evidence of a cmv infection, especially in the case where a primary infection should occur during pregnancy.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01509 |
| MDR Report Key | 5996523 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-10-04 |
| Date of Report | 2016-10-11 |
| Date of Event | 2016-09-07 |
| Date Mfgr Received | 2016-09-08 |
| Date Added to Maude | 2016-10-04 |
| 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 | 2016-10-04 |
| Model Number | NA |
| Catalog Number | 04784618190 |
| Lot Number | 190233 |
| ID Number | NA |
| Device Expiration Date | 2017-02-28 |
| 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 | 2016-10-04 |