MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-25 for ELECSYS HSV-2 IGG IMMUNOASSAY manufactured by Roche Diagnostics.
[124683258]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[124683259]
The customer complained of (b)(6) results for 1 patient tested for elecsys hsv-1 igg immunoassay (hsv-1) and elecsys hsv-2 igg immunoassay (hsv-2) on a cobas 8000 e 602 module. This medwatch will cover (b)(6). Refer to medwatch with (b)(6) for information on the (b)(6) results. On (b)(6) 2018 the patient was "(b)(6)" by a polymerase chain reaction (pcr) test for (b)(6); the actual results were not provided. The same day the patient was tested by an immulite analyzer and the (b)(6) results were (b)(6). On (b)(6) 2018 a new sample was obtained and the patient had a "(b)(6)" pcr result for (b)(6); the actual results were not provided. The sample from (b)(6) 2018 was tested on the immulite analyzer and the (b)(6) results were (b)(6). The same sample was tested on the e602 module and the (b)(6) result was (b)(6) and the (b)(6) result was (b)(6). The laboratory took the sample from (b)(6) 2018 and ran additional tests for igm by the elisa method. The (b)(6) result was (b)(6) and the (b)(6) result was "(b)(6)" (actual result not provided). The (b)(6) test result from the vector-best method was (b)(6). The (b)(6) results from the e602 module were reported outside of the laboratory. There was no allegation that an adverse event occurred. There is an "(b)(6)" result of (b)(6) documented from (b)(6) 2018. This may be a result from the immulite method but this is not clear. It is not clear if this result is from a new sample or from the (b)(6) 2018 sample. Clarification on this has been requested but has not yet been provided. The customer was not having any calibration or qc issues. The e602 module serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03284 |
| MDR Report Key | 7906288 |
| Date Received | 2018-09-25 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-08-31 |
| Date Mfgr Received | 2018-09-04 |
| Date Added to Maude | 2018-09-25 |
| 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 | 0 |
| Brand Name | ELECSYS HSV-2 IGG IMMUNOASSAY |
| Generic Name | HERPES SIMPLEX VIRUS SEROLOGICAL ASSAYS |
| Product Code | MYF |
| Date Received | 2018-09-25 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | 258198 |
| 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 | 2018-09-25 |