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 2017-02-09 for CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS 04784596190 manufactured by Roche Diagnostics.
[67298313]
This event occurred in (b)(6). (b)(4). Medwatch expiration date - the expiration date was provided as september 2017.
Patient Sequence No: 1, Text Type: N, H10
[67298314]
The customer stated that they received an erroneous result for one patient sample tested for the elecsys cmv igg assay (cmvigg) on a cobas 6000 e 601 module (e601). The erroneous result was reported outside of the laboratory. The customer complains about the poor specificity of the cmvigg reagent. With the diasorin cmv igg and biorad cmv igm testing methods, a seroconversion is suspected in the patient. With the roche cmvigg method, the seroconversion is not clear. The igm rate increases, but the igg rate is stable from (b)(6) 2016 to (b)(6) 2017. The first sample from the patient, dated (b)(6) 2016, resulted as (b)(6) for the elecsys cmv igm immunoassay ((b)(6)) when tested on the customer's e601 analyzer. This sample was repeated on the e601 analyzer on (b)(6) 2017, resulting as (b)(6). When the sample was tested with the diasorin cmv igg method, the result was (b)(6) and when tested with the biorad cmv igm method, the result was (b)(6) a second sample from the patient, dated (b)(6) 2016, resulted as (b)(6) when tested on the e601 analyzer. This sample was repeated on the e601 analyzer on (b)(6) 2017, resulting as (b)(6). A third sample from the patient, dated (b)(6) 2016, resulted as (b)(6) when tested on the e601 analyzer. When the sample was tested with the diasorin cmv igg method, the result was (b)(6) and when tested with the biorad cmv igm method, the result was (b)(6). The sample was also repeated with the diasorin cmv igg method,(b)(6). A fourth sample from the patient, dated (b)(6) 2017, resulted as (b)(6) when tested on the e601 analyzer. A fifth sample from the patient, dated (b)(6) 2017, resulted as (b)(6) when tested on the e601 analyzer. When the sample was tested with the diasorin cmv igg method, the result was (b)(6) and when tested with the biorad cmv igm method, the result was (b)(6). When this sample was tested with the biomerieux anti-cmv igg avidity method, the avidity was found to be (b)(6). The patient was not adversely affected. The serial number of the used e601 analyzer was requested, but not provided. Calibration and quality controls were within expected ranges.
Patient Sequence No: 1, Text Type: D, B5
[69978289]
Three samples from the patient were provided for investigation. One sample was dated (b)(6) 2016 and the other two samples were dated as (b)(6) 2017. Upon investigation, the sample from (b)(6) 2016 was determined to be non-reactive for the roche cmvigm assay and reactive for the roche cmvigg assay. The samples from (b)(6) 2017 were determined to be reactive for the roche cmvigm assay and reactive for the roche cmvigg assay. The results obtained by the customer were duplicated. The (b)(6) 2016 sample was determined to be negative using both the recomline cmv igm assay and cmv igg assay. The discrepancy observed with the roche cmvigg assay result is in line with those of other competitor results obtained by the customer for early samples of this patient. The (b)(6) 2017 samples were found to be reactive with both recomline cmv igm and cmv igg assays. The obtained reactivity pattern suggests an early phase infection. All samples from this patient showed reactive results with the roche cmvigg assay independent of the sampling date. A cmv igm seroconversion was concordantly determined with the first igm reactive sample from (b)(6) 2017 in both the elecsys cmv igm assay and the recomline cmv igm assay. Further analyses revealed that the samples of this patient showed dominant reactivity to only one out of five submodules of the elecsys cmv igg assay. This pattern is rare for a recent or persisting infection with cmv especially when observed over a longer period of time. In contrast, such a pattern can be associated with submodule specific interference. Taking these data together, a false-positive result for this patient in the roche cmvigg assay cannot be ruled out. The observed seroconversion for cmv igm together with the low avidity of cmv specific igg antibodies as determined by the customer can be indicative of a primary infection with cmv. As claimed in product labeling, single false positives can occur. The reagent was determined to be performing within specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00253 |
| MDR Report Key | 6313897 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-09 |
| Date of Report | 2017-03-14 |
| Date of Event | 2016-07-26 |
| Date Mfgr Received | 2017-01-19 |
| Date Added to Maude | 2017-02-09 |
| 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 | CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS |
| Generic Name | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS |
| Product Code | LFZ |
| Date Received | 2017-02-09 |
| Model Number | NA |
| Catalog Number | 04784596190 |
| Lot Number | 174473 |
| 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 | 2017-02-09 |