MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2016-01-12 for TOTAL PROTEIN URINE/CSF manufactured by Roche Diagnostics.
[35685995]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[35685996]
Henemyre-harris, c. L. , samols, m. , wenick, a. S. , & sokoll, l. J. (2014). Glow stick or urine sample? The clinical chemist, 60(2), 425-431. This journal article examined the effects of fluorescein given intravenously 2 hours before urine collection for a retinal angiography for 1 patient sample tested for total protein urine. A urine sample was collected from a 43 year old female with systemic lupus erythematosus. The urine sample was observed to be a bright yellow color. The initial total protein result from an aution max ax-4280 instrument was negative for protein. The corresponding result from the c701 instrument was 448 mg/dl (reference interval is < or = 12 mg/dl). It is not known if erroneous results were reported outside of the laboratory. It is not known if an adverse event occurred. No adverse event was reported. The c701 instrument serial number was not provided. The study indicates that fluorescein persists in the urine for 24-36 hours. The study advises that urine samples should be collected before angiography procedures to avoid interference in the urine.
Patient Sequence No: 1, Text Type: D, B5
[39351726]
Roche product labeling indicates that samples for urinary/csf protein should be collected before fluorescein is given or at least 24 hours later.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00040 |
| MDR Report Key | 5360773 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2016-01-12 |
| Date of Report | 2016-03-01 |
| Date of Event | 2013-02-01 |
| Date Mfgr Received | 2015-12-28 |
| Date Added to Maude | 2016-01-12 |
| 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 | TOTAL PROTEIN URINE/CSF |
| Generic Name | TURBIDIMETRIC, TOTAL PROTEIN |
| Product Code | JGQ |
| Date Received | 2016-01-12 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NA |
| Device Availability | * |
| 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 | 2016-01-12 |