MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-18 for LDL_C LDL-CHOLESTEROL PLUS 2ND GENERATION manufactured by Roche Diagnostics.
[75611327]
This event occurred in (b)(6). Unique identifier (udi)#: asku.
Patient Sequence No: 1, Text Type: N, H10
[75611328]
The customer questioned results for 1 patient tested for ldl_c ldl-cholesterol plus 2nd generation (ldl_c), total cholesterol, hdl, and trig on a cobas 8000 c 702 module. Based on the information provided, the hdl and ldl_c results were erroneous and reported outside of the laboratory. The date of event was requested but has not been provided. This medwatch will cover ldl_c. Refer to medwatch with (b)(6) for information on the hdl erroneous results. The initial hdl result from the c702 module was 10 (unit of measure not provided). The repeat hdl result using sekisui reagent was 45 (unit of measure not provided). The initial ldl_c result from the c702 module was 54 (unit of measure not provided). The repeat ldl result using sekisui reagent was 713 (unit of measure not provided). Both sets of results were reported outside of the laboratory with a note indicating that the sekisui results were performed using a different assay and that there was suspected lp(x) interference. No adverse event occurred. The patient was not affected due to the roche results. The patient sample was then tested by electrophoresis where the alpha? Fraction was 0. 9, the free beta-fraction was 13. 3 and the beta-fraction was 85. 8. Based on the reference ranges, the beta-fraction result of 85. 8 was high and hyperlipoproteinemia was suspected. The c702 module serial number was not provided.
Patient Sequence No: 1, Text Type: D, B5
[75837590]
The date in event date is an approximate date; the customer stated the event occurred in (b)(6) 2016. The unit of measure for total cholesterol, trig, hdl, ldl_c was mg/dl.
Patient Sequence No: 1, Text Type: N, H10
[76641592]
Patient Sequence No: 1, Text Type: N, H10
[132591052]
A specific root cause was not identified. Additional related test results were requested for investigation but could not be provided. The patient has hepatitis, vanishing bile duct syndrome and osteoporosis in both knees. In patients with these conditions, the presence of lp(x) and/or lp(y) lipoproteins can be assumed. These proteins can only be observed using a particular type of lipoprotein electrophoresis. These particles are not detected or barely detected in roche's ldlc3 assay. With changed liver patterns, it is possible that different direct test methods give very different results depending on the sensitivity to abnormal lipoproteins.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01026 |
| MDR Report Key | 6574753 |
| Date Received | 2017-05-18 |
| Date of Report | 2017-08-03 |
| Date of Event | 2016-01-01 |
| Date Mfgr Received | 2017-04-27 |
| Date Added to Maude | 2017-05-18 |
| 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 | 3 |
| Brand Name | LDL_C LDL-CHOLESTEROL PLUS 2ND GENERATION |
| Generic Name | LOW DENSITY LIPOPROTEIN TEST SYSTEM |
| Product Code | MRR |
| Date Received | 2017-05-18 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| ID Number | NA |
| 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 | 2017-05-18 |