MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-04 for IGG ANTIBODIES TO HERPES SIMPLEX VIRUS TYPE 1 05572185160 manufactured by Roche Diagnostics.
[44510568]
(b)(6). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[44510569]
The customer complained of erroneous results for 1 patient when tested for igg antibodies to (b)(6) and igg antibodies to (b)(6). It is not known if erroneous results were reported outside of the laboratory. This medwatch will cover (b)(6). Refer to medwatch with patient identifier (b)(6) for information on the (b)(6) erroneous results. The (b)(6) results were "repeatedly (b)(6)" on the e601 analyzer. The actual results were not provided. A serum sample was tested on a (b)(6) system and the result was (b)(6). No adverse event occurred. The e601 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[45810591]
It was noted that no medical decisions were made based on the hsv-1 igg results.
Patient Sequence No: 1, Text Type: N, H10
[46713357]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided.
Patient Sequence No: 1, Text Type: N, H10
[47844315]
It was clarified that during the original incident, both a serum sample and a csf sample were tested on a siemens bepiii system and a ratio result was issued. This ratio results is then assessed according to a specified cut off. The results were 24. 6 (positive). Patient sample is not available for investigation and no additional information is available for further investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00581 |
| MDR Report Key | 5629961 |
| Date Received | 2016-05-04 |
| Date of Report | 2016-06-21 |
| Date of Event | 2016-03-22 |
| Date Mfgr Received | 2016-04-13 |
| Date Added to Maude | 2016-05-04 |
| 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 | IGG ANTIBODIES TO HERPES SIMPLEX VIRUS TYPE 1 |
| Generic Name | ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-1 |
| Product Code | MXJ |
| Date Received | 2016-05-04 |
| Model Number | NA |
| Catalog Number | 05572185160 |
| Lot Number | ASKU |
| 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 | 2016-05-04 |