MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-17 for ELECSYS HSV-1 IGG IMMUNOASSAY 05572185160 manufactured by Roche Diagnostics.
[83749647]
Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83749648]
The customer received a questionable elecsys (b)(6) igg immunoassay result for one patient sample. The customer used cobas 6000 e 601 module serial number (b)(4). The initial result was 0. 560 coi ((b)(6)) and was reported outside the laboratory. The doctor doubted the result as the patient was previously (b)(6). The sample was sent to a reference laboratory and tested on a siemens immulyte (both (b)(6)) and the result was (b)(6). No specific data was provided. The sample was then sent another reference laboratory and the result was 1. 94 coi ((b)(6)). The patient was redrawn on (b)(6) 2017 and the result was from the cobas e601 was again (b)(6). They sent the sample to another laboratory and the result was (b)(6). Specific data was not provided. The patient was not adversely affected. For troubleshooting, the customer repeated a proficiency sample and the results were acceptable. The field service representative could not find a cause. He confirmed the customer repeated the sample with calibration, qc, and proficiency material and all results were within specification. The field application specialist could not find a cause. He reviewed and verified all data including calibration, qc, and methodologies. He verified the assay was performing to specification.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01724 |
| MDR Report Key | 6799984 |
| Date Received | 2017-08-17 |
| Date of Report | 2018-01-08 |
| Date of Event | 2017-07-13 |
| Date Mfgr Received | 2017-07-27 |
| Date Added to Maude | 2017-08-17 |
| 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 | 0 |
| Brand Name | ELECSYS HSV-1 IGG IMMUNOASSAY |
| Generic Name | HERPES SIMPLEX VIRUS, HSV-1 |
| Product Code | MXJ |
| Date Received | 2017-08-17 |
| Model Number | NA |
| Catalog Number | 05572185160 |
| Lot Number | 214509 |
| 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 | 2017-08-17 |