MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-31 for HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION 04399803190 manufactured by Roche Diagnostics.
[54339336]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[54339337]
Since (b)(6) 2015, the customer received questionable hdlc3 hdl-cholesterol plus 3rd generation and ldl_c ldl-cholesterol plus 3nd generation results when compared to the results received for chol2 cholesterol gen. 2. The sum of the hdl and ldl results did not fit to the cholesterol result. In some cases, the results did not fit to the disease of the patient. Data was provided from two cobas c501 analyzers. The serial number for one analyzer was (b)(4). The serial number of the other analyzer was requested, but was not provided. This medwatch is for the hdl assay. Refer to the medwatch with (b)(6) for the ldl assay. The specific number of patient samples involved was unknown. Data was provided for 65 patient samples. Refer to the attachments to the medwatch for all patient data. The customer believed the results for cholesterol to be correct and the results for hdl and ldl to be incorrect. Information concerning if any erroneous result was reported outside the laboratory was requested, but it was unknown. There was no adverse event. Upon review of the patient data, it was assumed the root cause was abnormal liver function of the patients as many low hdl results and low ldl/chol results were noted with other liver parameters out of the normal range. Based on the provided analyzer data, the system performance of both c501 analyzers was acceptable. Therefore a general issue with systems was excluded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2016-01293 |
| MDR Report Key | 5919245 |
| Date Received | 2016-08-31 |
| Date of Report | 2016-08-31 |
| Date of Event | 2015-10-01 |
| Date Mfgr Received | 2016-08-10 |
| Date Added to Maude | 2016-08-31 |
| 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 |
| 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 | HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION |
| Generic Name | CHOLESTEROL VIA ESTERASE-OXIDASE, HDL |
| Product Code | LBS |
| Date Received | 2016-08-31 |
| Model Number | NA |
| Catalog Number | 04399803190 |
| Lot Number | 618203 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-08-31 |