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 2018-02-22 for TOTAL PROTEIN URINE/CSF GEN.3 03333825190 manufactured by Roche Diagnostics.
[101030330]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[101030331]
The customer complained of erroneous results for a urine sample for 1 patient tested for tpuc3 total protein urine/csf gen. 3 (tpuc3) on a cobas 6000 c (501) module. The erroneous results were reported outside of the laboratory. A sample from this patient "in the fall" was tested for tpuc3 on the c501 module with a result of 1. 08 g/l. The sample was tested by the beckman method (colorimetric application) and the result was 0. 09 (unit of measure not provided). On (b)(6) 2018 the tpuc3 result on the c501 module was 0. 28 g/l. The sample was tested by the colorimetric application and the result was 0. 12 (unit of measure not provided). The customer stated the urine sample was clear. There was no allegation that an adverse event occurred. The c501 module serial number was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00545 |
| MDR Report Key | 7288329 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-22 |
| Date of Report | 2018-05-01 |
| Date of Event | 2017-09-13 |
| Date Mfgr Received | 2018-02-05 |
| Date Added to Maude | 2018-02-22 |
| 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 GEN.3 |
| Generic Name | TURBIDIMETRIC, TOTAL PROTEIN |
| Product Code | JGQ |
| Date Received | 2018-02-22 |
| Model Number | NA |
| Catalog Number | 03333825190 |
| 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 | 2018-02-22 |