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 2017-08-24 for TOTAL PROTEIN URINE/CSF GEN.3 03333825190 manufactured by Roche Diagnostics.
[84084644]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[84084645]
The customer states that they received erroneous results for one patient urine sample tested for tpuc3 total protein urine/csf gen. 3 (tpuc) on a cobas 6000 c (501) module - c501. No erroneous results were reported outside of the laboratory. The sample initially resulted as 0. 09 g/l. The sample was repeated on (b)(6) 2017, resulting as 0. 19 g/l. The sample was manually diluted 1:20 and tested twice on (b)(6) 2017, resulting as 12. 82 g/l accompanied by a data flag and 12. 96 g/l accompanied by a data flag. The sample was manually diluted 1:50 and tested twice on (b)(6) 2017, resulting as 113. 38 g/l accompanied by a data flag and 112. 06 g/l accompanied by a data flag. No adverse events were alleged to have occurred with the patient. The c501 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01808 |
| MDR Report Key | 6816373 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-24 |
| Date of Report | 2017-09-01 |
| Date of Event | 2017-08-06 |
| Date Mfgr Received | 2017-08-07 |
| Date Added to Maude | 2017-08-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2017-08-24 |
| Model Number | NA |
| Catalog Number | 03333825190 |
| Lot Number | 223039 |
| ID Number | NA |
| Device Expiration Date | 2018-05-31 |
| 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 | 2017-08-24 |