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 2016-11-14 for ELECSYS SYPHILIS 06923348190 manufactured by Roche Diagnostics.
[59748482]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[59748483]
The customer received questionable (b)(6) results for one patient sample from cobas e601 serial number (b)(4). On (b)(6) 2016, the patient was a prospective blood donor and was tested for (b)(6) antibodies with an abbott architect system and the result was (b)(6). The patient was treated with antibiotics. At that time, a test for treponema pallidum particle agglutination assay (tpha) was performed and the result was (b)(6). On (b)(6) 2016 after finishing the antibiotic treatment, the patient again attempted to donate blood. The patient was tested using the roche method and the result from the primary sample tube was (b)(6). On (b)(6) 2016, an aliquot of the sample was retested for confirmation and the (b)(6) was reproduced at (b)(6). A westernblot analysis (viramed) was performed: immuno-blot for (b)(6): (b)(6). Immuno-blot for (b)(6): (b)(6). The patient's (b)(6) result was always (b)(6). No specific data was provided. The doctor in charge was informed about the results, but no action was taken. The patient was not adversely affected. As a consequence of the unclear (b)(6) status of the patient, no blood from the (b)(6) 2016 donation was used and the patient stayed "blocked" for blood donation.
Patient Sequence No: 1, Text Type: D, B5
[67576027]
Samples from the patient were submitted for investigation. Based on the results of the investigation with multiple testing methods including western blot, tpla, and rpr2, both samples were found to be repeatedly negative/non-reactive. The negative results generated by the customer were determined to be the correct result for the samples. A general reagent issue could be excluded and no product problem was found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01769 |
| MDR Report Key | 6099020 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-14 |
| Date of Report | 2017-02-07 |
| Date of Event | 2016-10-07 |
| Date Mfgr Received | 2016-10-25 |
| Date Added to Maude | 2016-11-14 |
| 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 | ELECSYS SYPHILIS |
| Generic Name | ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM |
| Product Code | LIP |
| Date Received | 2016-11-14 |
| Model Number | NA |
| Catalog Number | 06923348190 |
| Lot Number | 159493 |
| 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 | 2016-11-14 |