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 HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION 05168805190 manufactured by Roche Diagnostics.
[83860405]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[83860406]
The customer received questionable ldl_c ldl-cholesterol plus 3rd generation and hdlc3 hdl-cholesterol plus 3rd generation results for one patient. Refer to the medwatch with patient identifier (b)(6) for the ldl assay. The doctor questioned why the ldl results were different between the different methods. The hdl result from the cobas analyzer was 0. 244 and the result from the beckman coulter au analyzer was 0. 97. The units of measure were requested but were not provided. The erroneous result was not reported outside the laboratory. There was no allegation of an adverse event. The customer used a cobas 8000 c 502 module. The serial number was requested but was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01807 |
| MDR Report Key | 6816365 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-24 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-08-01 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION |
| Generic Name | LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL |
| Product Code | LBS |
| Date Received | 2017-08-24 |
| Model Number | NA |
| Catalog Number | 05168805190 |
| Lot Number | 20076901 |
| ID Number | NA |
| Device Expiration Date | 2018-07-31 |
| 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 | 2017-08-24 |