MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-21 for TOTAL PROTEIN GEN.2 03183734190 manufactured by Roche Diagnostics.
[117854952]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[117854953]
The customer received questionable tp2 total protein gen. 2 results for one patient sample from cobas 6000 c 501 module serial number (b)(4). The initial result was 9. 0 g/dl and was reported outside of the laboratory. The repeat result with a 1:10 dilution was 9. 8 g/dl. The result by shikoku chuken method was 7. 7 g/dl. There was no allegation of an adverse event. As calibration and qc data were acceptable, a general reagent or application could be ruled out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02785 |
| MDR Report Key | 7800497 |
| Date Received | 2018-08-21 |
| Date of Report | 2018-09-14 |
| Date of Event | 2018-07-31 |
| Date Mfgr Received | 2018-08-02 |
| Date Added to Maude | 2018-08-21 |
| 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 | 0 |
| Brand Name | TOTAL PROTEIN GEN.2 |
| Generic Name | BIURET (COLORIMETRIC), TOTAL PROTEIN |
| Product Code | CEK |
| Date Received | 2018-08-21 |
| Model Number | NA |
| Catalog Number | 03183734190 |
| Lot Number | 335972 |
| Device Expiration Date | 2019-07-31 |
| 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 | 2018-08-21 |