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 2017-02-03 for CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS 04784596190 manufactured by Roche Diagnostics.
[66507244]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[66507245]
The customer stated that they have received an erroneous high result for one patient sample tested for the elecsys (b)(6) on a cobas 6000 e 601 module (e601). The erroneous result was reported outside of the laboratory. A first sample from the patient was tested on an e601 in the customer's laboratory on (b)(6) 2015 and resulted as 5. 7 u/ml ((b)(6)) for (b)(6). The result was obtained during the patient's first pregnancy and was not questioned. A second sample from the patient was tested in a second laboratory on an abbott architect analyzer on (b)(6) 2016, resulting as 0. 4 au/ml ((b)(6)) for (b)(6). A third sample from the patient was tested on the customer's e601 analyzer (serial number (b)(4)) on (b)(6) 2016 and the result was 27 u/ml ((b)(6)) for (b)(6). This sample was repeated at a third laboratory on an abbott architect analyzer on (b)(6) 2016, resulting as (b)(6) for (b)(6). The customer does not know if the patient is (b)(6) for (b)(6). The patient was not adversely affected.
Patient Sequence No: 1, Text Type: D, B5
[68620355]
A sample from the patient was provided for investigation. Investigations were able to duplicate the results of the customer. The sample showed clear reactivity with the roche cmvigg assay. There was no evidence for systemic interference of the sample with the general assay components. Antigen specific interference also appeared to be unlikely. The presence of cmv specific igg antibodies is supported by the recomline cmv igg assay, however, the detected signals are below the assay's cutoff (borderline result). The cmv specific igg antibodies were determined to be of high avidity (101%). This suggests that the patient had been remotely infected with cmv and has already acquired specific immunity. The root cause of the observed discrepancy between the roche cmvigg assay and the abbott assay could not be determined. Further testing of the patient with other independent methods, together with information on the clinical history of the patient may help to refine the diagnostic cmv status.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00213 |
| MDR Report Key | 6300774 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-03 |
| Date of Report | 2017-02-24 |
| Date of Event | 2016-12-15 |
| Date Mfgr Received | 2017-01-09 |
| Date Added to Maude | 2017-02-03 |
| 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 | 2017-02-03 |
| Model Number | NA |
| Catalog Number | 04784596190 |
| Lot Number | 174473 |
| ID Number | NA |
| Device Expiration Date | 2017-09-30 |
| 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 | 2017-02-03 |