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 2017-10-04 for LDL_C LDL-CHOLESTEROL PLUS 3ND GENERATION 07005717190 manufactured by Roche Diagnostics.
[88157299]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[88157300]
The customer received a questionable low ldl_c ldl-cholesterol plus 3rd generation result when compared to the results from a beckman coulter au640 analyzer. The result from the cobas 8000 c 502 module was 1. 93 mmol/l and the result from the au640 was 5. 53 mmol/l. The erroneous result was not reported outside of the laboratory. There was no allegation of an adverse event. The sample was inspected and was found to be lipemic. A specific root cause could not be identified. Based on the calibration and qc data provided, a general reagent issue was excluded. Review of the provided reaction data indicated the issue was related to the high triglyceride concentration in the sample. It was noted the customer was using a too short centrifugation time which may have affected the sample quality. The customer was also not using the sample cup adapters which may have caused a sampling error. The serial number of the cobas 8000 c 502 module was requested but was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02193 |
| MDR Report Key | 6913276 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-04 |
| Date of Report | 2017-10-04 |
| Date of Event | 2017-09-13 |
| Date Mfgr Received | 2017-09-16 |
| Date Added to Maude | 2017-10-04 |
| 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 3ND GENERATION |
| Generic Name | SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN |
| Product Code | MRR |
| Date Received | 2017-10-04 |
| Model Number | NA |
| Catalog Number | 07005717190 |
| Lot Number | 209151 |
| ID Number | NA |
| Device Expiration Date | 2018-06-30 |
| 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 | 2017-10-04 |