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 LDL_C LDL-CHOLESTEROL PLUS 3ND GENERATION 07005717190 manufactured by Roche Diagnostics.
[85278670]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[85278691]
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 hdl assay. The results were reported outside the laboratory and the doctor questioned why the ldl results were different between the different methods. The customer was previously using beckman coulter au and on (b)(6) 2017 the ldl result for the patient was 10. 13 mmol/l. On (b)(6) 2017, this sample was sent to a reference lab for a lipoprotein metabolism profile using electrophoresis, ultracentrifugation, and automated enzymatic beta quantitation. The result was 19 mmol/l. On (b)(6) 2017, the customer began using the roche ldl-c gen. 3 assay. On (b)(6) 2017, the same patient was tested and the result was 2. 69 mmol/l. The sample was repeated with a result of 2. 703 mmol/l. The sample was then repeated on a beckman au analyzer at a different site and the result was > 10. 3 mmol/l. 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 | 1823260-2017-01806 |
| MDR Report Key | 6816370 |
| 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 | LDL_C LDL-CHOLESTEROL PLUS 3ND GENERATION |
| Generic Name | SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN |
| Product Code | MRR |
| Date Received | 2017-08-24 |
| Model Number | NA |
| Catalog Number | 07005717190 |
| Lot Number | 20918801 |
| ID Number | NA |
| Device Expiration Date | 2018-11-30 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-24 |