MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-11-19 for TOTAL PROTEIN URINE/CSF GEN.3 03333825190 manufactured by Roche Diagnostics.
[4018968]
The customer alleged they received questionable total protein urine/csf gen. 3 (tpuc) results for one patient on their c501 analyzer. The patient's urine sample was initially tested undiluted and the result was 12 mg/dl. The initial result was reported outside the laboratory, but the physician questioned the result. The patient's sample was then diluted and the result was 14804 mg/dl. It was not confirmed whether the second result was reported to the physician. The customer also provided results from undiluted samples of 13. 2 mg/dl and 13. 2 mg/dl. It was assumed the results were from the same samples, but not confirmed. There were no adverse events. The tpuc reagent lot number was 683083 and the expiration date was 07/30/2014.
Patient Sequence No: 1, Text Type: D, B5
[11412929]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[21577753]
An investigation of the reaction kinetics indicated the sample had a very high turbidity. The very high protein content in the sample interferes with the analyzer's ability to correctly interpret the concentration. This limitation is stated in the package insert.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-07089 |
| MDR Report Key | 3476062 |
| Report Source | 01,05,06 |
| Date Received | 2013-11-19 |
| Date of Report | 2013-12-13 |
| Date of Event | 2013-11-03 |
| Date Mfgr Received | 2013-11-05 |
| Date Added to Maude | 2013-11-19 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| 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 GEN.3 |
| Generic Name | TURBIDIMETRIC, TOTAL PROTEIN |
| Product Code | JGQ |
| Date Received | 2013-11-19 |
| Model Number | NA |
| Catalog Number | 03333825190 |
| Lot Number | 683083 |
| ID Number | NA |
| Device Expiration Date | 2014-07-30 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-19 |