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 2017-12-14 for CHOL2 CHOLESTEROL GEN.2 manufactured by Roche Diagnostics.
[95832010]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[95832011]
The customer stated that they received erroneous results for two samples from the same patient tested for hdlc4 hdl-cholesterol plus 4th generation (hdl) and chol2 cholesterol gen. 2 (chol) on two cobas 6000 c (501) module (c501) analyzers. Both assays had results which did not fit with other lipid panel test results. Higher hdl results were obtained upon dilution of the second sample. This medwatch will apply to the chol assay measured on the second c501 analyzer. Please refer to the medwatch with patient identifier (b)(6) for information concerning the hdl assay measured on the first c501 analyzer. The second patient sample was diluted 1:5 and 1:50. Hdl measurements of the diluted sample were higher than those of the undiluted sample. An hdl value of 15 mg/dl was reported outside of the laboratory for the first sample. It was asked, but it is not known if any other test results were reported outside of the laboratory. No adverse events were alleged to have occurred with the patient. The serial numbers of the c501 analyzers were asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02924 |
| MDR Report Key | 7117097 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-14 |
| Date of Report | 2018-03-06 |
| Date of Event | 2017-11-23 |
| Date Mfgr Received | 2017-11-29 |
| Date Added to Maude | 2017-12-14 |
| 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 | CHOL2 CHOLESTEROL GEN.2 |
| Generic Name | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL |
| Product Code | CHH |
| Date Received | 2017-12-14 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-12-14 |